Z-0688-03

HeartMate Stroke Volume Limiter (SVL) Catalog # 1295

Name: Z-0688-03 HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
Creator: Thoratec Corp
Published: 2003-02-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-02-07 / Terminated

FDA source

Thoratec Corp began a recall of HeartMate Stroke Volume Limiter (SVL) Catalog # 1295 on 2003-02-07. The reason FDA records is "Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0688-03
Status: Terminated
Initiated: 2003-02-07
Posted: 2003-03-27
Terminated: 2003-10-09
Recalling firm: Abbott Medical
Product: HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
Product code: DSQ Ventricular (Assist) Bypass
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.
FDA 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, 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.
Product codes and lots: All Codes

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)