BEUDAMED
    FDA Recall Terminated

    Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604

    Recall: Z-0934-2007 · Initiated April 16, 2007

    Recall

    Recall Number
    Z-0934-2007
    Event Number
    37847
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 16, 2007
    Posted
    June 15, 2007
    Terminated
    February 24, 2008
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604

    Reason

    Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).

    Action

    Medtronic field personnel visited affected customers and retrieved product from this lot, unless the product was needed for an imminent scheduled surgery. Telephone scripts and leave behind letters to each consignee were initiated in April 2007.

    Distribution

    Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.

    Quantity

    31 kits