BEUDAMED
    FDA Enforcement Class I Ongoing

    ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators

    Recall: Z-1724-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1724-2023
    Event ID
    92328
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    May 10, 2023
    Classification Date
    June 16, 2023
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States

    Description

    ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators

    Reason

    There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

    Code Info

    GTIN 00763000615628, Lot Serial Numbers: RSM616778S, RSM610606S, RSM611337S, RSM610608S, RSM611339S; GTIN 00763000645502, Lot Serial Numbers: RSM616777S

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    6 units