FDA Medical Device Recalls (openFDA)
Thoratec Corp: HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
- Recall number
- Z-0688-03
- Recalling firm
- Thoratec Corp
- Product
- HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
- Status
- Terminated
- Initiated
- 2003-02-07
- Posted
- 2003-03-27
- Terminated
- 2003-10-09
- 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.
- Quantity
- not on file
- 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, H3A 1A1, Canada [Canadian Consignee # 2]: Transplant Surgeon Dr. Christopher M. Feindel MD FRCS(C), Toronto General Hospital, Division of Cardiothoracic Surgery, Toronto, Ontario, M5G 2CA, Canada.
- Lot, serial or model codes
- All Codes
- 510(k) numbers
- not on file
- PMA numbers
- ["P920014/S7"]
- Product code
- DSQ
- Firm FEI
- 2916596
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28