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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

506

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 481–500 of 506 recalls

Boston Scientific Corporation: PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIV...

Catheter separation immediately distal to the nose of the suture wing.

FDANov 22, 2004IN• Boston Scientific Corporation

Boston Scientific Corp: NAMIC Custom Angiographic Kit, Left Heart Kit - . Model...

The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.

FDAOct 21, 2004IL, IN, NV• Boston Scientific Corp

Boston Scientific Corp: NAMIC Custom Angiographic Kit, Left Heart Kit. - . Mode...

The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.

FDAOct 21, 2004IL, IN, NV• Boston Scientific Corp

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Boston Scientific Corporation: Manual Biopsy Devices containing AIM system: Chiba Needl...

Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.

FDAAug 9, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Express 2 Monorail Coronary Stent Systems (bare metal ste...

Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.

FDAJul 16, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corp: Boston Scientific brand Nephroureteral Stent System. Con...

Mislabeled as to size; 10FR are labeled as 8FR.

FDAJun 25, 2004MO• Boston Scientific Corp

Boston Scientific Corp: EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #9258000...

Product labeled to contain Emcee Obturators contained Emcee Dilators.

FDAJun 24, 2004IN, NJ• Boston Scientific Corp

Boston Scientific Corp: Boston Scientific/Microvasive brand Biliary Stent Kit, 7 ...

Mislabeled as to length; 10 cm length labeled as 5 cm.

FDAJun 18, 2004CA, HI, KY +2 more• Boston Scientific Corp

Boston Scientific Corp: Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2...

Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.

FDAJun 16, 2004Nationwide• Boston Scientific Corp

Boston Scientific Corporation: PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model...

Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.

FDAMay 25, 2004IN• Boston Scientific Corporation

Boston Scientific Corp: ''NAMIC Custom Angiographic Kit'' sold under the followi...

Molded handles used in Angiographic Manifolds may be occluded.

FDAMay 5, 2004IL, IN, KY +3 more• Boston Scientific Corp

Boston Scientific Corporation: Titanium Dual Lumen Implantable Port with PASV Valve and ...

Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.

FDAMar 29, 2004Nationwide• Boston Scientific Corporation

Boston Scientific Corp: Product in clear plastic pouch labeled: Boston Scientific...

Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.

FDAMar 18, 2004CA, CT, FL +8 more• Boston Scientific Corp

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: 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: VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains...

Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

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• 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