BEUDAMED
    FDA Recall Open, Classified

    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

    Recall: Z-1173-2024 · Initiated January 5, 2024

    Recall

    Recall Number
    Z-1173-2024
    Event Number
    93791
    Firm
    IMPULSE DYNAMICS (USA) INC
    FEI Number
    3017555074
    Product Code
    QFV
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 5, 2024
    Posted
    February 22, 2024
    Address
    50 Lake Center Executive Pky, # 100, Marlton, NJ, 08053

    Description

    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite

    Reason

    OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.

    Action

    On January 2, 2024, the firm sent letters to field representatives to be given to affected physicians. Summary of the safety communication can be found online: https://impulse-dynamics.com/safety-information/ The firm recommends all patients with implant card showing model CCM X11, who have experienced the "A9" charge error, charge their implanted device to no more than 75% of full capacity to circumvent the issue. See link above for instructions. If a patient encounters an A9 error code, CCM therapy has been suspended and must be manually reset. Patients should schedule time with an Impulse Dynamics representative or their physician to manually reset their device. The firm is working on a software update to address this issue. Patients and clinicians may determine if a specific device is affected by providing the serial number of any specific device to the Technical Support Hotline at 866-312-5370.

    Distribution

    Domestic US distribution nationwide. International distribution to Austria Croatia Czech Republic Germany Italy Macau Poland Romania Russia Spain Sweden.

    Quantity

    1,469 total units