Recall Z-0688-03 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
| Date | Mar 27, 2003 (initiated Feb 7, 2003) |
| Status | Terminated |
| Reason | Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur. |
| Root cause | Other |
| Action | The firm issued a Safety Bulletin and Safety Instructions to all consignees via certified mail with return receipts on 2/7/03. |
| Distribution | Product was released for distribution to 117 direct accounts nationwide and to 31 foreign accounts including 2 Canadian accounts. [Canadian Consignee #1]: Transplant Surgeon, Dr. Renzo Cecere, MD FRCS(C), Hospital Royal Victoria, Chirurgle Cardio-Thoracique, 687 Ave Des Pins Ouest, Montreal, Quebec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.