BEUDAMED
    FDA Recall Terminated

    Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.

    Recall: Z-0642-2009 · Initiated November 24, 2008

    Recall

    Recall Number
    Z-0642-2009
    Event Number
    50476
    Firm
    Medtronic Cardiovascular
    FEI Number
    3003311129
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 24, 2008
    Posted
    March 18, 2009
    Terminated
    March 27, 2009
    Address
    5355 Skylane Blvd, Santa Rosa, CA, 95403-1045

    Description

    Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.

    Reason

    Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.

    Action

    Medtronic sent a notification entitled "URGENT - VOLUNTARY MEDICAL DEVICE RECALL" to consignees on 11/21/2008. All products are to be returned to the firm's distribution center. For further information, please contact Medtronic Cardiovascular by telephone at 707-566-0111.

    Distribution

    Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS.

    Quantity

    23 units