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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

412

Past Year

Class I (Serious)

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 81–100 of 412 recalls

WallFlex PC Esoph Stent 18/23mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex ESO Stent LL 23x105 (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW FC 23mm 10.1cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

1...3 456 7...21

Page 5 of 21Next

FDA

Aug 1, 2024

Nationwide

• Boston Scientific Corporation

Agile ESO OTW PC 23mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex ESO Stent 18x103mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW FC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 10.1cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO FC RMV 23mm 6.2cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

WallFlex PC Esoph Stent 23/28mm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO FC RMV 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Flexima Regular Kit Nephrostomy Catheter System Kit, Mate... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

Flexima Regular Kit Biliary Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

VTC Regular Kit Nephrostomy Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Cathe... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

Flexima APDL Drainage Catheter System and Kit, Material N... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

FDAJul 18, 2024Nationwide• Boston Scientific Corporation

WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC... (Boston Scientific Neuromodulation Corporation) – spinal cord stimulation (scs) implant... (2024)

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

FDAJul 17, 2024Nationwide• Boston Scientific Neuromodulation Corporation

Capio SLIM Suture Device (Boston Scientific) – Capture Inconsistency (2024)

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

FDAJun 27, 2024Nationwide• Boston Scientific Corporation

Autotome RX Sphincterotome (Boston Scientific) - Wire Contamination (2024)

Laceration Risk

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.

FDAJun 12, 2024Nationwide• Boston Scientific Corporation

Boston Scientific Neuromodulation Corporation: Vercise Genus Deep Brain Stimulation (DBS) Implantable Pu...

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

FDAApr 18, 2024Nationwide• Boston Scientific Neuromodulation Corporation