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U.S. Department of Health and Human Services

Class 2 Device Recall HeartMate

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 Class 2 Device Recall HeartMatesee related information
Date Initiated by FirmFebruary 07, 2003
Date PostedMarch 27, 2003
Recall Status1 Terminated 3 on October 09, 2003
Recall NumberZ-0688-03
Recall Event ID 25631
PMA NumberP920014/S7 
Product Classification Ventricular (Assist) Bypass - Product Code DSQ
ProductHeartMate Stroke Volume Limiter (SVL) Catalog # 1295
Code Information All Codes
FEI Number 2916596
Recalling Firm/
Manufacturer		 Thoratec Corp
6035 Stoneridge Drive
Pleasanton CA 94588
For Additional Information ContactDonald A. Middlebrook
925-847-8600
Manufacturer 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 Determined
Cause 2		Other
ActionThe firm issued a Safety Bulletin and Safety Instructions to all consignees via certified mail with return receipts on 2/7/03.
DistributionProduct 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = DSQ
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