BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1173-2024 · Reported February 28, 2024

    Enforcement

    Recall Number
    Z-1173-2024
    Event ID
    93791
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    IMPULSE DYNAMICS (USA) INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2024
    Initiation Date
    January 5, 2024
    Classification Date
    February 22, 2024
    Address
    50 Lake Center Executive Pky /#100, N/A, Marlton, NJ, 08053, United States

    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.

    Code Info

    OPTIMIZER Smart Mini UDI-DI: 00810003380098 OPTIMIZER Lite UDI-DI: 00810003380142 All units potentially affected. The available software versions that allow the issue to manifest are 1.5.0 and 1.9.1.

    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