Boston Scientific Corporation
Marlborough, MA
This page shows every FDA and USDA recall linked to Boston Scientific Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
342
Total Recalls
2007
First Recall
2026
Most Recent
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;
Material Number (UPN): M00553680;
Feb 5, 2026
· Device
Open, Classified
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm;
Material Number (UPN): M00553530;
Feb 5, 2026
· Device
Open, Classified
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm;
Material Number (UPN): M00553560;
Feb 5, 2026
· Device
Open, Classified
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;
Material Number (UPN): M00553660;
Feb 5, 2026
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm;
Material Number (UPN): M00553520;
Feb 5, 2026
· Device
Open, Classified
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;
Material Number (UPN): M00553690;
Feb 5, 2026
· Device
Open, Classified
CX Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS I...
Oct 10, 2025
· Device
Open, Classified
CX Preconnect with TENACIO Pump without InhibiZone;
UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Oct 10, 2025
· Device
Open, Classified
TENACIO Pump without InhibiZone;
UPN: 72404420;
Oct 10, 2025
· Device
Open, Classified
CXR Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS...
Oct 10, 2025
· Device
Open, Classified
LGX Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS...
Oct 10, 2025
· Device
Open, Classified
LGX Preconnect with TENACIO Pump without InhibiZone;
UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Oct 10, 2025
· Device
Open, Classified
TENACIO Pump with InhibiZone;
UPN: 72404429;
Oct 10, 2025
· Device
Open, Classified
Extractor Pro RX Retrieval Balloon Catheter;
UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Ab...
Sep 23, 2025
· Device
Open, Classified
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553670
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553690
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553640
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553680
Jan 29, 2025
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm
UPN: M00553570
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553660
Jan 29, 2025
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553550
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm
UPN: M00553650
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Delivery System 10mmx10mm
UPN: M00553740
Jan 29, 2025
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm
UPN: M00553540
Jan 29, 2025
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm
UPN: M00553560
Jan 29, 2025
· Device
Open, Classified
AXIOS Stent and Delivery System 15mmx10mm
UPN: M00553750
Jan 29, 2025
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm
UPN: M00553530
Jan 29, 2025
· Device
Open, Classified
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm
UPN: M00553520
Jan 29, 2025
· Device
Open, Classified
AMS Artificial Urinary Sphincter Control Pump
Nov 25, 2024
· Device
Open, Classified
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Nov 25, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Sy...
Sep 26, 2024
· Device
Open, Classified
AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW S...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is I...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Sys...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Sy...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is In...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictu...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Sys...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System...
Sep 26, 2024
· Device
Open, Classified
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F-
Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW...
Sep 26, 2024
· Device
Open, Classified
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Sy...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Ste...
Sep 26, 2024
· Device
Open, Classified
AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW S...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is I...
Sep 26, 2024
· Device
Open, Classified
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Sy...
Sep 26, 2024
· Device
Open, Classified
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW S...
Sep 26, 2024
· Device
Open, Classified