Boston Scientific Corporation
414 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
FDA Devices Moderate Feb 5, 2025
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
FDA Devices Critical Jan 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model N…
FDA Devices Critical Jan 22, 2025
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
FDA Devices Critical Jan 22, 2025
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
FDA Devices Critical Jan 22, 2025
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
FDA Devices Moderate Dec 4, 2024
AMS Artificial Urinary Sphincter Control Pump
FDA Devices Moderate Dec 4, 2024
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
FDA Devices Critical Nov 20, 2024
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
FDA Devices Critical Nov 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
FDA Devices Critical Nov 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
FDA Devices Critical Nov 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
FDA Devices Critical Nov 20, 2024
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPIT…
FDA Devices Critical Nov 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to prov…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provid…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians wi…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide p…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physici…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to prov…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provid…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provi…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provi…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicia…
FDA Devices Moderate Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians wi…
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…
FDA Devices Moderate Oct 2, 2024
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 for maintaini…
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal …
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumin…
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
FDA Devices Moderate Oct 2, 2024
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 maintaining…
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
FDA Devices Moderate Oct 2, 2024
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 maintaining…
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esop…
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esoph…
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
FDA Devices Moderate Oct 2, 2024
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 for maintaini…
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
FDA Devices Moderate Oct 2, 2024