Recall Z-1470-2009 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced.
| Date | Jun 18, 2009 (initiated Mar 11, 2009) |
| Status | Terminated |
| Reason | Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. There have been 41 complaints in the US as |
| Root cause | Process change control |
| Action | Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated March 11, 2009. The letter was addressed to Risk Manager/Field Action Contacts describing the problem including instructions for affected device handling and a request to return the enclosed Reply Verification Tracking Form. Further questions can be addressed to Boston Scientific at 763-494-1634. |
| Quantity | U.S. and U.S. territories: 22,728; OUS: 11,308 |
| Distribution | Worldwide Distribution -- USA, United Arab Emirates, Dutch Antilles, Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Egypt, Spain, Finland, France, Great Britain, India, Indonesia, Ireland, Iraq, Italy, Jamaica, Japan, Kuwait, Sri Lanka, L |
| FDA record | Open on fda.gov |