BEUDAMED
    FDA Recall Open, Classified

    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

    Recall: Z-0206-2025 · Initiated September 24, 2024

    Recall

    Recall Number
    Z-0206-2025
    Event Number
    95489
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 24, 2024
    Posted
    October 23, 2024
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

    Reason

    A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.

    Action

    Medtronic neuromodulation issued an URGENT MEDICAL DEVICE RECALL notice to its consignees of 09/24/2024 via letter. The notice explained the issue, potential risk, and requested the affected devices in stock be returned. The notice is to be shared with those to whom the device was distributed. If the device has been implanted, the consignee was directed to contact their Medtronic Representative to determine if there are additional steps that may establish communication with the INS. On 07-Oct-24 and 08-Oct-24, a Medtronic representative successfully performed an update using a manufacturing software tool to reestablish communication to the affected devices. Consignees were provided a consignee notification regarding this action.

    Distribution

    International distribution to the countries of Germany, UK, and Israel.

    Quantity

    39 units