BEUDAMED
    FDA Recall Terminated

    HeartMate Stroke Volume Limiter (SVL) Catalog # 1295

    Recall: Z-0688-03 · Initiated February 7, 2003

    Recall

    Recall Number
    Z-0688-03
    Event Number
    25631
    Firm
    Thoratec Corp
    FEI Number
    2916596
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2003
    Posted
    March 27, 2003
    Terminated
    October 9, 2003
    Address
    6035 Stoneridge Drive, Pleasanton, CA, 94588

    Description

    HeartMate Stroke Volume Limiter (SVL) Catalog # 1295

    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.

    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.