BEUDAMED
    FDA Enforcement Class II Ongoing

    Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

    Recall: Z-0989-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0989-2022
    Event ID
    89825
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    St. Jude Medical, Cardiac Rhythm Management Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    March 10, 2022
    Classification Date
    April 21, 2022
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577, United States

    Description

    Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

    Reason

    Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

    Code Info

    REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

    Quantity

    2