BEUDAMED
    FDA Recall Terminated

    ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.

    Recall: Z-0389-2007 · Initiated December 6, 2006

    Recall

    Recall Number
    Z-0389-2007
    Event Number
    37006
    FEI Number
    2183870
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 6, 2006
    Posted
    February 1, 2007
    Terminated
    February 3, 2007
    Address
    Ev3 Inc 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.

    Reason

    Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.

    Action

    Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.

    Distribution

    IL, PA

    Quantity

    2