BEUDAMED
    FDA Recall Terminated

    Atlas VR, Models V-199

    Recall: Z-0149-06 · Initiated October 6, 2005

    Recall

    Recall Number
    Z-0149-06
    Event Number
    33807
    FEI Number
    2017865
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2005
    Posted
    November 16, 2005
    Terminated
    February 10, 2012
    Address
    St Jude Medical 15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Atlas VR, Models V-199

    Reason

    Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

    Action

    Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.

    Distribution

    Nationwide and Western Europe: Austria Belgium Denmark Finland France Germany Italy Netherlands Poland Portugal Spain Sweden UK Switzerland Greece Malta Eastern Europe: Czech Republic Lithuania Latvia Romania Bulgaria Croatia Slovenia Slovakia Russia Serbia Middle East! Africa: South Africa Israel Iran Iraq Jordan Lebanon Suadi Arabia Turkey Latin America: Argentina Brazil Chile Colombia EI Salvador Guatamala Mexico Uruguay Venezuela Asia-Pacific: China Hong Kong Malaysia Taiwan Thailand Australia-New Zealand: Australia New Zealand and Canada

    Quantity

    13097