BEUDAMED
    FDA Recall Open, Classified

    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

    Recall: Z-0988-2022 · Initiated March 10, 2022

    Recall

    Recall Number
    Z-0988-2022
    Event Number
    89825
    Firm
    St. Jude Medical, Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    March 10, 2022
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

    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.

    Action

    Abbott issued a Safety Notification For a subset of Gallant ICDS and CRT-D, Models CDVRA500Q, CDDRA500Q and CDHFA500Q on March 10, 2022. Notification was hand delivered in US. The notification includes the Patient Management Recommendations: -As the devices are unable to be followed using remote monitoring via Bluetooth connectivity, follow-ups should be conducted in-clinic using inductive telemetry. - Abbott has developed a process to attempt recovery of Bluetooth communication via a device firmware upgrade. If remote monitoring via Bluetooth communication is desired, please work with your local Abbott representative to schedule a firmware upgrade. Please complete and return the included Acknowledgement Form to [email protected] and maintain a record of this notice to ensure effectiveness of the communication. For any question, please contact Abbott Technical Support at 1-800-722-3774 (U.S.).

    Distribution

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

    Quantity

    1