BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

    Recall: Z-0200-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0200-2016
    Event ID
    72115
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 11, 2015
    Initiation Date
    September 29, 2015
    Classification Date
    November 2, 2015
    Termination Date
    March 9, 2016
    Address
    8200 Coral Sea St Ne, N/A, Saint Paul, MN, 55112-4391, United States

    Description

    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

    Reason

    64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

    Code Info

    Lot U531

    Distribution

    Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.

    Quantity

    64 units