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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 401–412 of 412 recalls

Boston Scientific Corporation: PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen ,...

Lumens may have incorrect lumen size marked on them.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK...

Lumens may have incorrect lumen size marked on them.

FDAMar 5, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, ...

Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.

FDAFeb 10, 2004Nationwide

1...19 2021

Page 21 of 21Next

• Boston Scientific Corporation

Boston Scientific Corporation: Wallstent Rx Biliary Endoprosthesis with Unistep Plus Del...

Incorrect label states stent covered with 'Permalume Covering', product is uncovered

FDAJan 28, 2004CA, GA, MD +4 more• Boston Scientific Corporation

Boston Scientific Corporation: ASAP Channel Cut Biopsy System, 14 gauge Reference Number...

Sterility of the device may be compromised due to a lack of package integrity

FDAJul 3, 2003Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Wallstent Enteral Endoprothesis with Unistep Plus Deliver...

Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm

FDAJun 26, 2003CO, FL, IL +4 more• Boston Scientific Corporation

Boston Scientific Corporation: Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog...

Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa

FDAJun 23, 2003Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: MaxForce TTS High Performance Esophageal Balloon Dilatati...

Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr

FDAApr 29, 2003CA, CO, FL +16 more• Boston Scientific Corporation

Boston Scientific Corporation: Polyflex Esophageal Stent 25/21mm x 90mm

Radiopaque marker bands may not be visible under fluoroscopy

FDAApr 16, 2003Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Polyflex Esophageal Stent 23/18mm x 90mm

Radiopaque marker bands may not be visible under fluoroscopy

FDAApr 16, 2003Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Polyflex Esophageal Stent 20/16mm x 90mm

Radiopaque marker bands may not be visible under fluoroscopy

FDAApr 16, 2003Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific/Microvasive Open End Ureteral Catheter ...

Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use

FDAMar 17, 2003Nationwide• Boston Scientific Corporation