BEUDAMED
    FDA Enforcement Class II Completed

    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

    Recall: Z-0217-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0217-2024
    Event ID
    93170
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2023
    Initiation Date
    May 27, 2022
    Classification Date
    November 2, 2023
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

    Reason

    There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

    Code Info

    UDI/DI 00763000274320, Serial Number VA2JV2V

    Distribution

    US: MO, FL, TX, WA

    Quantity

    14 units