BEUDAMED
    FDA Recall Open, Classified

    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation

    Recall: Z-1408-2023 · Initiated March 17, 2023

    Recall

    Recall Number
    Z-1408-2023
    Event Number
    91957
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 17, 2023
    Posted
    April 19, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation

    Reason

    Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

    Action

    Medtronic issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/17/2023 via UPS 2-day delivery. The notice explained the issue and the hazard and requested the following actions be taken: Quarantine all unused product from the affected lots and return them as described on the Customer Confirmation Form. Pass the notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.

    Quantity

    1414 units