Recall Z-2014-2009 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Boston Scientific Impulse Flextrusion Shaft, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX. Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilata
| Date | Sep 4, 2009 (initiated Aug 5, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Packaging |
| Action | 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. |
| Quantity | 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, Spain, Finland, France, Great Britain, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Jordan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc., Feb 10, 1997 |