Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Me

FDA device recall Z-2013-2009 · posted 2009-09-04 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile barrier in the packaging may be compromised. During internal inspections, they discovered gaps between the side seals and the top seal approximately 3/8 in len

Action taken

Boston Scientific issued an "Urgent Medical Device Recall Removal" letter dated August 5, 2009. The letter was addressed to Risk Manger / Field Action Contact. The letter described the problem and product involved. The Firm recommended to segregate affected product immediately and return to Boston Scientific and requested return of the "The Reply Verification Tracking Form" enclosed with the letter. For further questions, contact your local Boston Scientific Sales Representative or call 1-763-494-1634.

Root cause

Packaging

Status

Terminated

Product code

DQO

Quantity affected

27,892 (US 19,257; OUS 8,635)

Distribution

Worldwide Distribution -- US (including DC and Puerto Rico), Japan, United Arab Emirates, Albania, Austria, Belgium, Bulgaria, Bahrain, Switzerland, Czech Republic, Germany, Denmark, Algeria, Egypt, S

Date initiated

2009-08-05

Date posted

2009-09-04

Date terminated

2012-01-07

Location

Maple Grove, MN

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