BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0206-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0206-2025
    Event ID
    95489
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    September 24, 2024
    Classification Date
    October 23, 2024
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    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.

    Code Info

    GTIN 00763000813468, Serial Numbers: NND504236H, NND504252H; GTIN 00763000813475, Serial Numbers: NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H; GTIN 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H; GTIN A7630008135201, Serial Numbers: NND504167H, NND504178H, NND504180H; GTIN A7630008134701, Serial Numbers: NND504181H, NND504243H

    Distribution

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

    Quantity

    39 units