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Boston Scientific Corporation Recalls

383 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Boston Scientific Corporation.

383Total Recalls
91Critical
8.6MUnits Affected
Mar 30, 2026Most Recent
All Recalls

Every Boston Scientific Corporation Recall

Sorted by most recent. Click any recall for full details.

383 recalls
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
Medical Implants·1,144 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
Medical Implants·309 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
Medical Implants·31 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Medical Implants·495 affected·Dec 20, 2024
CriticalFDA
Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL ...
Cardiac Devices·156,329 affected·Dec 12, 2024
CriticalFDA
Boston Scientific Corporation
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Medical Devices·156,329 affected·Dec 12, 2024
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Cardiac Devices·156,329 affected·Dec 12, 2024
High RiskFDA
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Control Pump
Medical Devices·16 affected·Oct 28, 2024
High RiskFDA
Boston Scientific Corporation
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Medical Devices·52 affected·Oct 28, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Surgical Devices·20,290 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Surgical Devices·960 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Surgical Devices·368 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Surgical Devices·2,751 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CO...
Medical Devices·1,035 affected·Oct 10, 2024
CriticalFDA
Boston Scientific Corporation
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Surgical Devices·5,913 affected·Oct 10, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive dis...
Cardiac Devices·6 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive displ...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provid...
Cardiac Devices·9 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide p...
Cardiac Devices·161 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display ...
Cardiac Devices·2 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to pro...
Cardiac Devices·58 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive dis...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive displ...
Cardiac Devices·1 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·5 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive disp...
Cardiac Devices·92 affected·Sep 5, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintain...
Medical Implants·77 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended f...
Medical Implants·6 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·133 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining eso...
Medical Implants·507 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining...
Medical Implants·79 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esop...
Medical Implants·516 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·308 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·79 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·145 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for...
Medical Implants·7 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·146 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·39 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin...
Medical Implants·66 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·305 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for...
Medical Implants·18 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin...
Medical Implants·2 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining eso...
Medical Implants·364 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for main...
Medical Implants·124 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maint...
Medical Implants·231 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintain...
Medical Implants·77 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·199 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended f...
Medical Implants·6 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·115 affected·Aug 1, 2024