BEUDAMED
    FDA Recall Terminated

    ATS Open Pivot Mechanical Heart Valve

    Recall: Z-0634-04 · Initiated February 18, 2004

    Recall

    Recall Number
    Z-0634-04
    Event Number
    28356
    Firm
    ATS Medical, Inc.
    FEI Number
    3008592544
    Product Code
    LWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 18, 2004
    Posted
    July 20, 2004
    Terminated
    May 10, 2005
    Address
    3905 Annapolis Ln N, Ste 105, Minneapolis, MN, 55447-5473

    Description

    ATS Open Pivot Mechanical Heart Valve

    Reason

    Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.

    Action

    Notification is being made by ATS Medical representatives hand delivery of notification letters dated February 18, 2004 to consignees. Representatives will identify and inspect inventory and return any defective product to ATS Medical. The letter will be signed and returned to verify notification.

    Distribution

    Nationwide throughout the US and worldwide.

    Quantity

    56,266