BEUDAMED
    FDA Recall Terminated

    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

    Recall: Z-2602-2016 · Initiated June 10, 2016

    Recall

    Recall Number
    Z-2602-2016
    Event Number
    74545
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 10, 2016
    Terminated
    October 3, 2016
    Address
    7000 Central Ave, Minneapolis, MN, 55421-1241

    Description

    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

    Reason

    Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.

    Action

    Consignees were delivered in person by Medtronic Field Representatives a "Medical Device Removal" letter dated June 2016. The letter described the problem and the product involved in the recall. Advised consignees to return the unused product and to complete the Customer Confirmation Form. For questions contact Medtronic Technical Services at 800-707-09033 weekdays 7 am - 6 pm, or contact your Medtronic representative.

    Distribution

    US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.

    Quantity

    70