Recall Z-0839-2007 ยท MKI
EV3 Neurovascular
Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
| Date | Jun 7, 2007 (initiated Apr 5, 2007) |
| Status | Terminated |
| Reason | Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures. |
| Root cause | Other |
| Action | A recall plan was developed for 100% recovery of guidewires within affected lot numbers. The plan includes notification to U.S., European, and Rest-of-World customers and distributors. A recall notification letter was prepared 04/05/2007 which summarizes the coating problem and potential risks, identifies the affected lot numbers and quantities shipped to the customer, and provides instructions for return of unused guidewires. |
| Quantity | 2120 |
| Distribution | Worldwide, including USA, Italy, United Kingdom, Switzerland, Germany, Belgium, South Africa, Canada, Slovenia, China, Austria, France, Spain, Jordan, Mexico, Portugal, Colombia, Greece, Brazil, Venezula, Ireland, Australia, Malaysia, Saudi Arabia, South Korea, Lithuania, Netherlands, Hungary, and U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982543 | SILVERSTREAK HYDROPHILIC GUIDEWIRE Micro Therapeutics, Inc., Dec 11, 1998 |