BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT MEDICAL LIBERATOR LOCKING STYLET

    MDR report key: 24604470 · Received March 16, 2026

    Report

    Report Number
    MW5185230
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 6, 2026
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    DRB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE LIBERATOR LOCKING STYLET MANUFACTURED BY MERIT MEDICAL IS USED FOR PACEMAKER AND DEFIBRILLATOR LEAD EXTRACTIONS. IT IS DESIGNED TO TOLERATE SIGNIFICANT PULLING FORCE AS THAT TRACTION IS REQUIRED FOR SUCCESSFUL REMOVAL OF CHRONIC LEADS. FOR THE PAST THREE MONTHS - EVERY LIBERATOR LOCKING STYLET I HAVE USED HAS BROKEN IN THE SAME PLACE - THE WELD POINT IN THE MIDDLE - THIS IS DESPITE USING LESS AND LESS FORCE TO AVOID BREAKING THE STYLET. OTHERS HAVE REPORTED SIMILAR. I AM CONCERNED THAT THE LIBERATOR LOCKING STYLET IS NO LONGER SAFE TO BE USED IN HIGH-RISK PROCEDURES, SUCH AS LEAD EXTRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663374 MERIT MEDICAL LIBERATOR LOCKING STYLET STYLET, CATHETER DRB COOK VANDERGRIFT INC. G26550

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other