BEUDAMED
    FDA Enforcement Class II Terminated

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    Recall: Z-2349-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2349-2018
    Event ID
    80148
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    FHC, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2018
    Initiation Date
    May 10, 2018
    Classification Date
    July 5, 2018
    Termination Date
    April 30, 2019
    Address
    1201 Main St, Bowdoin, ME, 04287-7302, United States

    Description

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    Reason

    The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.

    Code Info

    UDI: 00873263004418

    Distribution

    The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.

    Quantity

    2952 total