BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2602-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2602-2016
    Event ID
    74545
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    June 10, 2016
    Classification Date
    August 19, 2016
    Termination Date
    October 3, 2016
    Address
    7000 Central Ave, Minneapolis, MN, 55421-1241, United States

    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.

    Code Info

    lots: VA15GPJ, VA15K3N, VA15K7K

    Distribution

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

    Quantity

    70