HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
FDA device recall Z-0688-03 · posted 2003-03-27 · Terminated
Recall details
- Recalling firm
- Thoratec Corp
- Reason for recall
- Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.
- Action taken
- The firm issued a Safety Bulletin and Safety Instructions to all consignees via certified mail with return receipts on 2/7/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSQ
- 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
- Date initiated
- 2003-02-07
- Date posted
- 2003-03-27
- Date terminated
- 2003-10-09
- Location
- Pleasanton, CA
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