BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic InterStim Ground Pad REF 041826

    Recall: Z-2365-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2365-2023
    Event ID
    92701
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    July 6, 2023
    Classification Date
    August 10, 2023
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic InterStim Ground Pad REF 041826

    Reason

    Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

    Code Info

    Product Number: 041826; UDI: 20763000343273; Lot Number: 60347246

    Distribution

    International distribution to the country of Iran.

    Quantity

    360 packs (36 kits of 10 packs each)