BEUDAMED
    FDA Recall Completed

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

    Recall: Z-0217-2024 · Initiated May 27, 2022

    Recall

    Recall Number
    Z-0217-2024
    Event Number
    93170
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Completed
    Root Cause
    Labeling Change Control
    Initiated
    May 27, 2022
    Posted
    November 3, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    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.

    Action

    Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail. The notice explained the issue, potential risk, and requested the return of the affected product.

    Distribution

    US: MO, FL, TX, WA

    Quantity

    14 units