EPA (Environmental Protection Agency)
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epa_echo
1 records
fda
485 records
FDA Recall: Boston Scientific Corporation — Class I
20260506
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization t | Product: Boston Scientific Cardiac Resynchroniz...
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FDA Device Recall: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Materi
2026-02-11
Class I — Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to e...
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FDA Device Recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material
2026-02-11
Class I — Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to e...
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FDA Device Recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Mat
2026-02-11
Class I — Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to e...
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FDA Device Recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material N
2026-02-11
Class I — Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to e...
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FDA Recall: Boston Scientific Corporation — Class I
20251022
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery | Product: Model Number L211 PROPONENT DR SL MRI ...
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FDA Recall: Boston Scientific Corporation — Class I
20251022
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery | Product: Model Number S702, ALTRUA 2 DR SL Pace...
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FDA Recall: Boston Scientific Corporation — Class II
20250917
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An in | Product: Boston Scientific NephroMax Kit, Mater...
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FDA Recall: Boston Scientific Corporation — Class I
20250910
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventila | Product: WATCHMAN TruSeal Access System SGL, US...
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FDA Recall: Boston Scientific Corporation — Class II
20250716
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic in | Product: Torflex Transseptal Guiding Sheath Kit...
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FDA Recall: Boston Scientific Corporation — Class II
20250205
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolong | Product: AXIOS Stent and Delivery System 10mmx1...
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FDA Recall: Boston Scientific Corporation — Class I
20250122
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mod | Product: PROPONENT DR Pacemaker, SL (Model Numb...
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FDA Device Recall: Model Number L211 PROPONENT DR SL MRI Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number S702, ALTRUA 2 DR SL Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number U128, VALITUDE CRT-P EL MRI
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number L231, PROPONENT DR EL MRI Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: TENACIO Pump without InhibiZone; UPN: 72404420;
2025-10-22
Class II — The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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FDA Device Recall: Model Number L101, ESSENTIO DR SL Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number L209 PROPONENT DR (VDD) SL Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number U226, VISIONIST CRT-P EL
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: TENACIO Pump with InhibiZone; UPN: 72404429;
2025-10-22
Class II — The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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FDA Device Recall: PROPONENT SR SL (Model L200)
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number U228, VISIONIST CRT-P EL MRI
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM I
2025-10-22
Class II — The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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FDA Device Recall: Model Number L221 PROPONENT DR EL Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number L131, ESSENTIO DR EL MRI Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: ACCOLADE DR EL MRI (Model L331)
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number L121 ESSENTIO DR EL Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Model Number L110, ESSENTIO SR SL MRI Pacemaker
2025-10-22
Class I — Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE famil...
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FDA Device Recall: Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2
2025-09-17
Class II — The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that du...
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FDA Device Recall: ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Mater
2025-09-17
Class II — Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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FDA Device Recall: Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
2025-09-17
Class II — Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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FDA Device Recall: Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200,
2025-09-17
Class II — The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that du...
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FDA Device Recall: WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; inten
2025-09-10
Class I — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature ...
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FDA Device Recall: WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; int
2025-09-10
Class I — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature ...
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FDA Device Recall: WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; inten
2025-09-10
Class I — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature ...
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FDA Device Recall: WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; inten
2025-09-10
Class I — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature ...
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FDA Device Recall: WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; inte
2025-09-10
Class I — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature ...
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FDA Device Recall: WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; inten
2025-09-10
Class I — Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature ...
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FDA Device Recall: ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Pe
2025-08-27
Class I — Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most ...
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FDA Device Recall: RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead,
2025-08-27
Class I — Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most ...
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FDA Device Recall: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
2025-08-20
Class II — The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
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FDA Device Recall: Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63
2025-07-16
Class II — Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenar...
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FDA Device Recall: VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF
2025-07-16
Class II — Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenar...
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FDA Device Recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t
2025-07-16
Class II — Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenar...
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FDA Device Recall: VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 6
2025-07-16
Class II — Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenar...
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FDA Device Recall: IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needl
2025-05-07
Class II — Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affe...
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FDA Device Recall: IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles
2025-05-07
Class II — Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affe...
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FDA Device Recall: IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needle
2025-05-07
Class II — Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affe...
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FDA Device Recall: AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M005
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005536
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005536
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
2025-02-05
Class II — Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the ...
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FDA Device Recall: PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL
2025-01-22
Class I — A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, high...
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FDA Device Recall: VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
2025-01-22
Class I — A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, high...
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FDA Device Recall: ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (M
2025-01-22
Class I — A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, high...
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FDA Recall: Boston Scientific Corporation — Class II
20241204
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (U | Product: AMS Artificial Urinary Sphincter Contr...
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FDA Recall: Boston Scientific Corporation — Class I
20241120
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistu | Product: Boston Scientific POLARx BALLOON CATHE...
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FDA Recall: Boston Scientific Corporation — Class I
20241120
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistu | Product: Boston Scientific POLARx FIT BALLOON C...
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FDA Recall: Boston Scientific Corporation — Class II
20241002
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Product: WALLFLEX FC ESO STENT RMV LL 18X103- Wa...
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FDA Recall: Boston Scientific Corporation — Class II
20241002
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Product: AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 F...
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FDA Recall: Boston Scientific Corporation — Class II
20241002
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Product: WALLFLEX PC ESOPH STENT 23/28MM X 105MM...
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FDA Recall: Boston Scientific Corporation — Class II
20241002
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Product: WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wa...
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FDA Recall: Boston Scientific Corporation — Class II
20241002
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Product: WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM-...
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FDA Recall: Boston Scientific Corporation — Class II
20240925
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. | Product: VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M00...
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FDA Recall: Boston Scientific Corporation — Class II
20240925
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. | Product: Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers RE...
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FDA Recall: Boston Scientific Corporation — Class I
20240522
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t | Product: Expo 5F Selective Angiographic Cathete...
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FDA Recall: Boston Scientific Corporation — Class I
20240522
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t | Product: Expo 5F Selective Angiographic Cathete...
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FDA Recall: Boston Scientific Corporation — Class I
20240522
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t | Product: Expo 5F Selective Angiographic Cathete...
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FDA Recall: Boston Scientific Corporation — Class I
20240522
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t | Product: Expo 5F Selective Angiographic Cathete...
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FDA Recall: Boston Scientific Corporation — Class I
20240522
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t | Product: Expo 5F Selective Angiographic Cathete...
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FDA Recall: Boston Scientific Corporation — Class I
20240522
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t | Product: Expo 5F Selective Angiographic Cathete...
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FDA Recall: Boston Scientific Corporation — Class II
20240417
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the | Product: EndoVive 20 Fr Safety PEG Push w/ENFit...
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FDA Device Recall: AMS Artificial Urinary Sphincter Control Pump
2024-12-04
Class II — Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
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FDA Device Recall: AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
2024-12-04
Class II — Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
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FDA Device Recall: Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2
2024-11-20
Class I — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
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FDA Device Recall: Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS206
2024-11-20
Class I — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
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FDA Device Recall: Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS216
2024-11-20
Class I — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
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FDA Device Recall: Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS21
2024-11-20
Class I — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
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FDA Device Recall: Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRB
2024-11-20
Class I — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
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FDA Device Recall: Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2
2024-11-20
Class I — Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EV
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM -
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JA
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM -
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM -
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO IN
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO +
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO +
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
View Source
FDA Device Recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EV
2024-10-23
Class II — Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected ...
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FDA Device Recall: WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC)
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (P
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and F
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and F
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fu
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC)
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) an
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC)
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) an
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and F
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (P
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC)
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (P
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) a
2024-10-02
Class II — WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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FDA Device Recall: VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300;
2024-09-25
Class II — There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
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FDA Device Recall: Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00127
2024-09-25
Class II — There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
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FDA Device Recall: vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Materia
2024-09-25
Class II — There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
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FDA Device Recall: Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650
2024-09-25
Class II — There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
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FDA Device Recall: Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, In
2024-08-07
Class II — Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
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FDA Device Recall: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M005
2024-07-24
Class II — Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H7490852
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3),
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), R
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3),
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H74908526
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H749
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H749
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H749
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H74908
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H7490
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H7490
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3),
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3),
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749085
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
View Source
FDA Device Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490852
2024-05-22
Class I — An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and i...
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FDA Device Recall: EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutriti
2024-04-17
Class II — Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for an...
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FDA Device Recall: EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrit
2024-04-17
Class II — Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for an...
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FDA Device Recall: EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutritio
2024-04-17
Class II — Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for an...
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FDA Device Recall: Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013
2024-04-03
Class I — An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most se...
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FDA Device Recall: OptiCross Coronary Imaging Catheter, REF H749518080120
2024-04-03
Class II — Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
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FDA Device Recall: Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ins
2024-01-17
Class II — The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
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FDA Recall: Boston Scientific Corporation — Class II
20231011
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted pr | Product: Guider Softip Guide Catheter 5F 100CM ...
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FDA Recall: Boston Scientific Corporation — Class II
20231011
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted pr | Product: Guider Softip Guide Catheter 8F 90CM M...
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FDA Recall: Boston Scientific Corporation — Class II
20231011
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted pr | Product: Guider Softip Guide Catheter 5F PRE-SH...
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FDA Recall: Boston Scientific Corporation — Class II
20230524
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. | Product: WATCHDOG Hemostasis Valve Kit, UPN H74939343A02...
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FDA Recall: Boston Scientific Corporation — Class II
20230426
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy lea | Product: Habib EndoHPB Bipolar Radiofrequency (...
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FDA Device Recall: EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN#
2023-11-29
Class II — Poor image quality due to fluid ingress in the lens.
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FDA Device Recall: EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner b
2023-11-29
Class II — Poor image quality due to fluid ingress in the lens.
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FDA Device Recall: Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630,
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, c
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, c
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, c
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, c
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, c
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470,
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, c
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480,
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440,
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620,
2023-10-11
Class II — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curv...
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FDA Device Recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D
2023-08-30
Class II — There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
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FDA Device Recall: Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a devi
2023-08-02
Class II — Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use m...
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FDA Device Recall: Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a dev
2023-08-02
Class II — Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use m...
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FDA Device Recall: Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ene
2023-08-02
Class II — Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use m...
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FDA Device Recall: Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that t
2023-08-02
Class II — Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use m...
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FDA Device Recall: Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ene
2023-08-02
Class II — Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use m...
View Source
FDA Device Recall: WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A
2023-05-24
Class II — The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
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FDA Device Recall: WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H749393
2023-05-24
Class II — The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
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FDA Device Recall: Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency
2023-04-26
Class II — Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage...
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FDA Device Recall: LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Softwa
2023-03-15
Class II — Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patie...
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FDA Recall: Boston Scientific Corporation — Class II
20221109
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. | Product: EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A...
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FDA Recall: Boston Scientific Corporation — Class II
20220504
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructi | Product: SpaceOAR System, UPN SO-1010, SO-2101,...
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FDA Recall: Boston Scientific Corporation — Class II
20220323
Sterility of device is compromised due to a sterile barrier breach | Product: HYDRATOME RX 44-20MM/450CM Material Number: M00583060
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FDA Recall: Boston Scientific Corporation — Class II
20220323
Sterility of device is compromised due to a sterile barrier breach | Product: JAGTOME RX 44-20-260-035 Material Number: M00573040
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FDA Recall: Boston Scientific Corporation — Class II
20220323
Sterility of device is compromised due to a sterile barrier breach | Product: HYDRATOME RX 49-20MM/260CM Material Number: M00583000
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FDA Recall: Boston Scientific Corporation — Class II
20220323
Sterility of device is compromised due to a sterile barrier breach | Product: DREAMTOME 44-30MM/260CM Material Number: M00584050
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FDA Device Recall: EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
2022-11-09
Class II — There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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FDA Device Recall: EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which
2022-11-09
Class II — Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
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FDA Device Recall: EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
2022-11-09
Class II — There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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FDA Device Recall: The PRM is intended to be used as part of the ZOOM LATITUDE Programming System t
2022-09-07
Class II — There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Sc...
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FDA Device Recall: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
2022-08-31
Class II — The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
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FDA Device Recall: EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a
2022-08-10
Class II — Product may be mislabeled.
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FDA Device Recall: EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use
2022-05-25
Class II — Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, ...
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FDA Device Recall: EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use
2022-05-25
Class II — Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, ...
View Source
FDA Device Recall: EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use:
2022-05-25
Class II — Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, ...
View Source
FDA Device Recall: SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporaril
2022-05-04
Class II — Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that desc...
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FDA Device Recall: SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the
2022-05-04
Class II — Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that desc...
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FDA Device Recall: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
2022-04-20
Class II — Pouch seals may be open, compromising sterility.
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FDA Device Recall: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
2022-04-20
Class II — Pouch seals may be open, compromising sterility.
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FDA Device Recall: HYDRATOME RX 44-20MM/450CM Material Number: M00583060
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: JAGTOME RX 44-20-260-035 Material Number: M00573040
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: HYDRATOME RX 49-20MM/260CM Material Number: M00583000
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: DREAMTOME 44-30MM/260CM Material Number: M00584050
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: JAGTOME RX 39-30-260-025 Material Number: M00573100
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: JAGTOME RX 39-20-450-025 Material Number: M00573090
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: DREAMTOME 49-20MM/260CM Material Number: M00584000
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: DREAMTOME 49-30MM/450CM Material Number: M00584030
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: JAGTOME RX 49-20-260-035 Material Number: M00573000
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: DREAMTOME 44-30MM/450CM Material Number: M00584070
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: HYDRATOME RX 44-20MM/260CM Material Number: M00583040
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: DREAMTOME 49-30MM/260CM Material Number: M00584010
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: HYDRATOME RX 49-30MM/260CM Material Number: M00583010
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
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FDA Device Recall: JAGTOME RX 44-30-260-035 Material Number: M00573060
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Device Recall: JAGTOME RX 39-30-450-025 Material Number: M00573110
2022-03-23
Class II — Sterility of device is compromised due to a sterile barrier breach
View Source
FDA Recall: Boston Scientific Corporation — Class II
20211222
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal n | Product: Boston Scientific ROTAPRO, Rotational ...
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FDA Recall: Boston Scientific Corporation — Class II
20211208
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | Product: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of stricture...
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FDA Recall: Boston Scientific Corporation — Class II
20211208
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | Product: HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures ...
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FDA Recall: Boston Scientific Corporation — Class II
20210714
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time result | Product: Accolade pacemaker, Models: a) L300 ...
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FDA Recall: Boston Scientific Corporation — Class II
20210421
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. | Product: MAMBA Flex 135 Microcatheter. Packaged with protecti...
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FDA Recall: Boston Scientific Corporation — Class I
20210127
There is potential for fractures which results in the inability to delivery therapy. | Product: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator
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FDA Recall: Boston Scientific Corporation — Class I
20210120
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the d | Product: Lotus Edge Valve System, Transcatheter...
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FDA Recall: Boston Scientific Corporation — Class I
20210120
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the d | Product: Lotus Edge Valve System, Transcatheter...
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FDA Recall: Boston Scientific Corporation — Class II
20210113
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparatio | Product: Hot AXIOS Stent and Electrocautery - E...
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FDA Recall: Boston Scientific Corporation — Class II
20210113
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparatio | Product: AXIOS Stent and Electrocautery - Enhan...
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FDA Device Recall: Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers
2021-12-22
Class II — Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of stricture
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures o
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures o
2021-12-08
Class II — Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
View Source
FDA Device Recall: TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
2021-08-25
Class II — Potential for leaks and loosening at the patient catheter connection
View Source
FDA Device Recall: INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
2021-07-21
Class I — The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery...
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FDA Device Recall: INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
2021-07-21
Class I — The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery...
View Source
FDA Device Recall: INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/
2021-07-21
Class I — The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery...
View Source
FDA Device Recall: Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L3
2021-07-14
Class II — Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of...
View Source
FDA Device Recall: VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
2021-07-14
Class II — Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of...
View Source
FDA Device Recall: Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
2021-07-14
Class II — Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of...
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FDA Device Recall: VICI VENOUS STENT System Product Usage: is intended for the treatment of obst
2021-05-26
Class I — The firm has received reports of stent migration after implantation
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FDA Device Recall: UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage:
2021-05-05
Class II — Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
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FDA Device Recall: Colpassist Vaginal Positioning Device - Product Usage: intended for use in gener
2021-05-05
Class II — Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
View Source
FDA Device Recall: EXALT Controller - Product Usage: intended for use with a Boston Scientific endo
2021-05-05
Class III — May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
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FDA Device Recall: The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system contain
2021-04-28
Class II — An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
View Source
FDA Device Recall: MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, se
2021-04-21
Class II — The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
View Source
FDA Device Recall: Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare
2021-03-10
Class II — Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
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FDA Device Recall: Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Oute
2021-03-10
Class II — Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
View Source
FDA Device Recall: EMBLEM S-ICD Model A209
2021-02-17
Class I — Electrical overstress may lead to device malfunction.
View Source
FDA Device Recall: EMBLEM MRI S-ICD Model A219
2021-02-17
Class I — Electrical overstress may lead to device malfunction.
View Source
FDA Device Recall: EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model
2021-02-03
Class II — Accelerated battery depletion may result in a need for device replacement earlier than expected.
View Source
FDA Device Recall: EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mo
2021-02-03
Class II — Accelerated battery depletion may result in a need for device replacement earlier than expected.
View Source
FDA Device Recall: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardio
2021-01-27
Class I — There is potential for fractures which results in the inability to delivery therapy.
View Source
FDA Device Recall: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Del
2021-01-20
Class I — Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
View Source
FDA Device Recall: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Del
2021-01-20
Class I — Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
View Source
FDA Device Recall: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Del
2021-01-20
Class I — Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
View Source
FDA Device Recall: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Del
2021-01-20
Class I — Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
View Source
FDA Device Recall: Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Del
2021-01-20
Class I — Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
View Source
FDA Device Recall: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) U
2021-01-13
Class II — The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in ...
View Source
FDA Device Recall: AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553
2021-01-13
Class II — The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in ...
View Source
FDA Device Recall: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) U
2021-01-13
Class II — The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in ...
View Source
FDA Recall: Boston Scientific Corporation — Class II
20201230
Complaint trend regarding needle shaft gas leaks. | Product: IceSeed" 1.5 Cryoablation Needle
View Source
FDA Recall: Boston Scientific Corporation — Class II
20201230
Complaint trend regarding needle shaft gas leaks. | Product: IcePearl" 2.1 CX 90¿ Cryoablation Needle
View Source
FDA Recall: Boston Scientific Corporation — Class II
20201230
Complaint trend regarding needle shaft gas leaks. | Product: IceRod" 1.5 CX 90¿ Cryoablation Needle¿
View Source
FDA Recall: Boston Scientific Corporation — Class II
20201230
Complaint trend regarding needle shaft gas leaks. | Product: Five IceSphere" Prostate Cryoablation Kit
View Source
FDA Recall: Boston Scientific Corporation — Class II
20201230
Complaint trend regarding needle shaft gas leaks. | Product: IcePearl" 2.1 CX Cryoablation Needle
View Source
FDA Recall: Boston Scientific Corporation — Class II
20201223
This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional int | Product: EKOS Control System (CU) 4.0. UPN 600-...
View Source
FDA Recall: Boston Scientific Corporation — Class II
20200812
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as i | Product: Captivator Polypectomy Snare, Single-U...
View Source
FDA Recall: Boston Scientific Corporation — Class II
20200812
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as i | Product: Captivator Polypectomy Snare, Single-U...
View Source
FDA Recall: Boston Scientific Corporation — Class II
20200729
The needle surface deteriorated due to unexpected electrolysis during procedure. | Product: Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Gali
View Source
FDA Recall: Boston Scientific Corporation — Class II
20200729
The needle surface deteriorated due to unexpected electrolysis during procedure. | Product: Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Presc
View Source
FDA Recall: Boston Scientific Corporation — Class II
20200729
The needle surface deteriorated due to unexpected electrolysis during procedure. | Product: Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Me
View Source
FDA Recall: Boston Scientific Corporation — Class II
20200506
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the | Product: MoXy Laser Fiber, Material Number 0010...
View Source
FDA Recall: Boston Scientific — Class II
20200429
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to ex | Product: Percuflex Plus Ureteral Stent Set 6FX2...
View Source
FDA Recall: Boston Scientific — Class II
20200429
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to ex | Product: Polaris Ultra Ureteral Stent Set 6FX24...
View Source
FDA Recall: Boston Scientific — Class II
20200429
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to ex | Product: Sensor Nitinol Wire with Hydrophilic T...
View Source
FDA Recall: Boston Scientific Corporation — Class I
20200401
Potential for tip detachment of Imager II 5F Angiographic Catheters | Product: Imager II 5F Angiographic Catheters, 5 units per package.
View Source
FDA Device Recall: IceSeed" 1.5 Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IcePearl" 2.1 CX 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceRod" 1.5 CX 90¿ Cryoablation Needle¿
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: Five IceSphere" Prostate Cryoablation Kit
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IcePearl" 2.1 CX Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceRod" 1.5 i-Thaw" Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceSeed" 1.5 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceSeed" 1.5 MRI Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceSphere" 1.5 CX 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceSphere" 1.5 Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceSphere" 1.5 S 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceFORCE" 2.1 CX 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceRod" 1.5 PLUS 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: Five IceRod" i-Thaw" Prostate Cryoablation Kit
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceSeed" Prostate Cryoablation Kit
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: Three IcePearl" 2.1 CX Prostate Cryoablation Kit
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IcePearl" 2.1 CX L 90¿ Cryoablation Needle
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: IceRod" 1.5 MRI Cryoablation Needle¿
2020-12-30
Class II — Complaint trend regarding needle shaft gas leaks.
View Source
FDA Device Recall: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular
2020-12-23
Class II — This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatu...
View Source
FDA Device Recall: AMS 700 MS Pump with and without InhibiZone, sold as individual units and also p
2020-11-18
Class II — The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has diff...
View Source
FDA Device Recall: Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNI
2020-11-11
Class II — There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
View Source
FDA Device Recall: Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP)
2020-11-04
Class II — Incorrectly installed base.
View Source
FDA Device Recall: Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexibl
2020-08-12
Class II — BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure ...
View Source
FDA Device Recall: Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexibl
2020-08-12
Class II — BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure ...
View Source
FDA Device Recall: Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexibl
2020-08-12
Class II — BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure ...
View Source
FDA Device Recall: Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexibl
2020-08-12
Class II — BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure ...
View Source
FDA Device Recall: Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable
2020-08-12
Class II — BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure ...
View Source
FDA Device Recall: Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Presc
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visu
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescript
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescr
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Presc
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription
2020-07-29
Class II — The needle surface deteriorated due to unexpected electrolysis during procedure.
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FDA Device Recall: MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be us
2020-05-06
Class II — To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip ...
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FDA Device Recall: iLab Polaris Multi-Modality Guidance System; iLab Ultrasound
2020-05-06
Class II — Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will ar...
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FDA Device Recall: Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
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FDA Device Recall: Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
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FDA Device Recall: Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006670
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
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FDA Device Recall: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
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FDA Device Recall: Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
View Source
FDA Device Recall: Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00667
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
View Source
FDA Device Recall: Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
View Source
FDA Device Recall: Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
2020-04-29
Class II — An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
View Source
FDA Device Recall: Imager II 5F Angiographic Catheters, 5 units per package.
2020-04-01
Class I — Potential for tip detachment of Imager II 5F Angiographic Catheters
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FDA Device Recall: Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The B
2020-03-25
Class II — Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programm...
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FDA Recall: Boston Scientific Corporation — Class II
20191204
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month | Product: Boston Scientific Advanix Pancreatic S...
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FDA Recall: Boston Scientific Corporation — Class II
20191204
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month | Product: Boston Scientific Advanix Pancreatic S...
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FDA Recall: Boston Scientific Corporation — Class II
20191204
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month | Product: Boston Scientific Advanix Pancreatic S...
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FDA Recall: Boston Scientific Corporation — Class II
20191204
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month | Product: Boston Scientific Advanix Pancreatic S...
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FDA Recall: Boston Scientific Corporation — Class II
20190529
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to | Product: AURIGA 30 BRAZIL ZERO COST SYSTEM UP...
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FDA Recall: Boston Scientific Corporation — Class II
20190529
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to | Product: AURIGA 30 GENERAL ZERO COST SYSTEM ...
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FDA Recall: Boston Scientific Corporation — Class III
20190116
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material com | Product: IntellaNav MiFi Open-Irrigated Ablatio...
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FDA Device Recall: AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 10
2019-12-25
Class II — Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
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FDA Device Recall: Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Us
2019-12-18
Class II — During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy tran...
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FDA Device Recall: Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Us
2019-12-18
Class II — During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy tran...
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm U
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm U
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UP
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
View Source
FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
View Source
FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm U
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm U
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide.
2019-12-04
Class II — Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during t...
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FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm U
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
View Source
FDA Device Recall: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UP
2019-12-04
Class II — Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
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FDA Device Recall: Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Package
2019-12-04
Class II — Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during t...
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FDA Device Recall: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as E
2019-09-25
Class II — Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing a...
View Source
FDA Device Recall: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as E
2019-09-25
Class II — Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing a...
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FDA Device Recall: AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 724
2019-09-11
Class II — Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
View Source
FDA Device Recall: AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auri
2019-05-29
Class II — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displaye...
View Source
FDA Device Recall: AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Au
2019-05-29
Class II — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displaye...
View Source
FDA Device Recall: AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auri
2019-05-29
Class II — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displaye...
View Source
FDA Device Recall: AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007
2019-05-29
Class II — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displaye...
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FDA Device Recall: AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 400
2019-05-29
Class II — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displaye...
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FDA Device Recall: AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga
2019-05-29
Class II — Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displaye...
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FDA Device Recall: Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Mater
2019-03-20
Class II — The sterile barrier may contain packaging seal defects.
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FDA Device Recall: IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigat
2019-01-16
Class III — Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in ...
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FDA Device Recall: Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigate
2019-01-16
Class III — Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in ...
View Source
FDA Device Recall: IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigat
2019-01-16
Class III — Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in ...
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FDA Recall: Boston Scientific Corporation — Class II
20180516
Potential for Capio sutures to break and /or detach. | Product: Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during o
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FDA Recall: Boston Scientific Corporation — Class II
20180516
Potential for Capio sutures to break and /or detach. | Product: Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing app
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FDA Recall: Boston Scientific Corporation — Class II
20180328
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Product: Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrosto
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FDA Recall: Boston Scientific Corporation — Class II
20180314
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly | Product: Auriga XL 4007 Laser System, Universal...
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FDA Recall: Boston Scientific Corporation — Class II
20180124
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacema | Product: PROPONENT SR Pacemaker
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FDA Recall: Boston Scientific Corporation — Class II
20180124
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacema | Product: ACCOLADE DR Pacemaker
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FDA Recall: Boston Scientific Corporation — Class II
20180124
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacema | Product: ACCOLADE SR Pacemaker
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FDA Device Recall: Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, M
2018-10-31
Class II — Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
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FDA Device Recall: VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
2018-10-03
Class II — Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery de...
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FDA Device Recall: PROPONENT Pacemaker
2018-10-03
Class II — Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery de...
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FDA Device Recall: ACCOLADE Pacemaker
2018-10-03
Class II — Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery de...
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FDA Device Recall: Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neuro
2018-08-15
Class II — Potential polymer material degradation.
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FDA Device Recall: Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing a
2018-05-16
Class II — Potential for Capio sutures to break and /or detach.
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FDA Device Recall: Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in
2018-05-16
Class II — Potential for Capio sutures to break and /or detach.
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FDA Device Recall: PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue
2018-05-16
Class II recall by Boston Scientific Corporation
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FDA Device Recall: Capio CL; Model #M0068311350. Indicated for the placement of suture in a vari
2018-05-16
Class II — Potential for Capio sutures to break and /or detach.
View Source
FDA Device Recall: Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 T
2018-03-28
Class II — Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
View Source
FDA Device Recall: Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 0
2018-03-28
Class II — Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
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FDA Device Recall: Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005
2018-03-28
Class II — Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
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FDA Device Recall: SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
2018-03-28
Class II — Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
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FDA Device Recall: Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended t
2018-03-14
Class II — Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in er...
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FDA Device Recall: Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be use
2018-03-14
Class II — Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in er...
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FDA Device Recall: Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and de
2018-02-28
Class II — Stent possibly unable to be fully released from the delivery system.
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FDA Device Recall: PROPONENT SR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ACCOLADE DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ACCOLADE SR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
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FDA Device Recall: VISIONIST CRT-P Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
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FDA Device Recall: ESSENTIO DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
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FDA Device Recall: ALTRUA 2 EL DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
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FDA Device Recall: ACCOLADE MRI EL DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
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FDA Device Recall: PROPONENT DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: VALITUDE CRT-P Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
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FDA Device Recall: PROPONENT EL DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ACCOLADE MRI DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ACCOLADE MRI SR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ESSENTIO SR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ALTRUA 2 SR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ESSENTIO MRI SR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: ESSENTIO MRI EL DR Pacemaker
2018-01-24
Class II — Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization thera...
View Source
FDA Device Recall: RESONATE X4 CRT-D, Model G447, Sterile.
2017-11-15
Class II — The devices have an incorrect firmware configuration.
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FDA Device Recall: RESONATE EL ICD VR, Model D432, Sterile.
2017-11-15
Class II — The devices have an incorrect firmware configuration.
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FDA Device Recall: MOMENTUM X4 CRT-D, Model G138, Sterile.
2017-11-15
Class II — The devices have an incorrect firmware configuration.
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FDA Device Recall: RESONATE EL ICD DR, Model D433, Sterile.
2017-11-15
Class II — The devices have an incorrect firmware configuration.
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FDA Device Recall: VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy D
2017-11-15
Class II — The devices have an incorrect firmware configuration.
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FDA Device Recall: FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intend
2017-09-20
Class II — The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
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FDA Device Recall: SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended
2017-08-23
Class II — The device can deliver an atypical amount of energy due to memory corruption inside the device.
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FDA Device Recall: EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillato
2017-08-23
Class II — The device can deliver an atypical amount of energy due to memory corruption inside the device.
View Source
FDA Device Recall: Boston Scientific Imager II Angiographic Catheter, a pathway for delivering cont
2017-07-12
Class II — A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
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FDA Device Recall: Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below U
2017-07-12
Class II — Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the ...
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FDA Device Recall: The JETSTREAM is a rotational atherectomy catheter system designed for use in de
2017-05-10
Class II — Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85...
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FDA Device Recall: Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer pack
2017-04-19
Class II — One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package conta...
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FDA Device Recall: AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Car
2017-03-15
Class II — Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.
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FDA Device Recall: Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
2017-02-15
Class II — There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. T...
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FDA Device Recall: Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
2017-01-11
Class II — Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was n...
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FDA Recall: Boston Scientific Corporation — Class II
20160420
Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found | Product: Boston Scientific, PT Graphix Magnet J...
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FDA Device Recall: Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X
2016-05-04
Class II — Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
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FDA Device Recall: Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Prod
2016-04-27
Class I — Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snar...
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FDA Device Recall: Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coati
2016-04-20
Class II — Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a ...
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FDA Device Recall: Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices trea
2016-01-20
Class II — The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
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FDA Device Recall: Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8
2016-01-13
Class II — Potential for separation of the proximal handle from the shaft.
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FDA Recall: Boston Scientific Corporation — Class I
20151118
Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conju | Product: RotaWire Elite and wireClip Torquer, G...
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FDA Recall: Boston Scientific Corporation — Class II
20150819
AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date | Product: AngioJet SOLENT Dista Thrombectomy Set...
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FDA Recall: Boston Scientific Corporation — Class II
20150408
Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional | Product: Various Lots of Expel Drainage Cathete...
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FDA Device Recall: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM
2015-12-30
Class II — During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation...
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FDA Device Recall: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M00
2015-12-30
Class II — During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentatio...
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FDA Device Recall: Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxid
2015-12-30
Class I — Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. T...
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FDA Device Recall: RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device
2015-11-18
Class I — Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational At...
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FDA Device Recall: RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device
2015-11-18
Class I — Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational At...
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FDA Device Recall: Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Int
2015-11-18
Class II — Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likeliho...
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FDA Device Recall: Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery S
2015-09-23
Class II — Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinf...
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FDA Device Recall: Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Sing
2015-09-23
Class II — Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinf...
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FDA Device Recall: AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Ster
2015-08-19
Class II — AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
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FDA Device Recall: AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 1
2015-08-19
Class II — AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
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FDA Device Recall: AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Usi
2015-08-19
Class II — AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
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FDA Device Recall: Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Cath
2015-07-08
Class II — One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
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FDA Device Recall: CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, usi
2015-06-24
Class II — Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become ove...
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FDA Device Recall: Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Cathe
2015-04-08
Class II — Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval usi...
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FDA Device Recall: Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage C
2015-04-08
Class II — Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmen...
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FDA Recall: Boston Scientific Corporation — Class II
20140319
The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequen | Product: Boston Scientific, RunWay Guide Cathet...
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FDA Recall: Boston Scientific Corporation — Class II
20140122
Sterility of device may be compromised due to lack of pouch seal integrity | Product: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (U
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FDA Recall: Boston Scientific Corporation — Class II
20140122
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size | Product: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above ...
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FDA Device Recall: IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0;
2014-12-17
Class II — Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
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FDA Device Recall: StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
2014-10-15
Class II — Product is not cleared for use with lasers other than the Auriga XL system
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FDA Device Recall: IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve
2014-06-25
Class II — Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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FDA Device Recall: IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Cur
2014-06-25
Class II — Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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FDA Device Recall: IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric C
2014-06-25
Class II — Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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FDA Device Recall: IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Cur
2014-06-25
Class II — Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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FDA Device Recall: iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultra
2014-04-30
Class II — Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the Longview distance measur...
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FDA Device Recall: Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3896
2014-03-19
Class II — The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a...
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FDA Device Recall: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univers
2014-01-22
Class II — Sterility of device may be compromised due to lack of pouch seal integrity
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FDA Device Recall: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Ab
2014-01-22
Class II — Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
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FDA Device Recall: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intende
2014-01-22
Class II — Sterility of device may be compromised due to lack of pouch seal integrity
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FDA Device Recall: TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universa
2014-01-22
Class II — Sterility of device may be compromised due to lack of pouch seal integrity
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FDA Device Recall: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects
2014-01-22
Class II — Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
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FDA Device Recall: TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univers
2014-01-22
Class II — Sterility of device may be compromised due to lack of pouch seal integrity
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FDA Device Recall: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects A
2014-01-22
Class II — Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
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FDA Device Recall: TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universa
2014-01-22
Class II — Sterility of device may be compromised due to lack of pouch seal integrity
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FDA Device Recall: Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280,
2013-12-11
Class II — The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
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FDA Device Recall: Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiat
2013-09-11
Class II — Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutt...
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FDA Device Recall: RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554
2013-07-17
Class III — Product labeled with incorrect expiration date.
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FDA Device Recall: Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical device
2012-10-24
Class II — Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Port...
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FDA Device Recall: LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (
2012-10-24
Class II — Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Port...
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FDA Device Recall: Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562
2012-06-27
Class II — Difficulty in extending snare loop from the catheter
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FDA Device Recall: Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M005625
2012-06-27
Class II — Difficulty in extending snare loop from the catheter
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FDA Device Recall: Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562
2012-06-27
Class II — Difficulty in extending snare loop from the catheter
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lobbying
6 records
Lobbying Client: BOSTON SCIENTIFIC CORPORATION
Lobbied by ALSTON & BIRD LLP — Innovative medical solutions company.
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Lobbying Client: BOSTON SCIENTIFIC
Lobbied by HOLLIER & ASSOCIATES — Medical Device Manufacturer
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Lobbying Client: BOSTON SCIENTIFIC
Lobbied by HOLLIER & ASSOCIATES — Medical Device Manufacturer
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Lobbying Client: BOSTON SCIENTIFIC
Lobbied by HOLLIER & ASSOCIATES — Medical Device Manufacturer
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Lobbying Client: BOSTON SCIENTIFIC CORPORATION
Lobbied by ALSTON & BIRD LLP — Innovative medical solutions company.
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ny_corps
1 records
NY Corp: BOSTON SCIENTIFIC CORPORATION
1998-01-28
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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SEC EDGAR
1 records
sec_efts
1 records
SEC Filing: BOSTON SCIENTIFIC CORP
2024-01-08
SEC EDGAR filing — Forms: 8-K — Query: merger acquisition
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USASpending
3 records
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