BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

    Recall: Z-1564-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1564-2013
    Event ID
    65458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    June 12, 2013
    Classification Date
    June 21, 2013
    Termination Date
    November 19, 2013
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391, United States

    Description

    Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

    Reason

    Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.

    Code Info

    Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.

    Distribution

    Internationally distributed: to countries of Germany and Poland.

    Quantity

    15