Boston Scientific Impulse Flextrusion Shaft, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico,
FDA device recall Z-2014-2009 · 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
- 391,788 (US 212,299; OUS 155,599)
- 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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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K964859) | Scimed Life Systems, Inc. | 1997-02-10 |