BEUDAMED
    FDA Enforcement Class I Ongoing

    ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators

    Recall: Z-1801-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1801-2023
    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 DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; 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 00763000115647, Lot Serial Numbers: EVR600484S, EVR600487S, EVR600488S, EVR600489S, EVR600490S, EVR600492S, EVR600494S, EVR600479S, EVR600480S, EVR600483S, EVR600500S, EVR600495S, EVR600496S, EVR600478S, EVR600516S, EVR600517S, EVR600519S, EVR600521S, EVR600522S, EVR600525S, EVR600526S

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    21 units