BEUDAMED
    FDA Enforcement Class I Ongoing

    ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators

    Recall: Z-1795-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1795-2023
    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-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; 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 00643169720466, Lot Serial Numbers: BWI218211H, BWI218218H, BWI218226H, BWI218228H, BWI218206H, BWI218224H, BWI218210H, BWI218222H, BWI218217H, BWI218214H, BWI218216H, BWI218208H, BWI218207H, BWI218221H, BWI218212H, BWI218220H

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    16 units