BEUDAMED
    FDA Recall Terminated

    microTargeting" Drive System, Product Number MT-DS-01

    Recall: Z-2346-2018 · Initiated May 10, 2018

    Recall

    Recall Number
    Z-2346-2018
    Event Number
    80148
    Firm
    FHC, Inc.
    FEI Number
    3002250546
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2018
    Terminated
    April 30, 2019
    Address
    1201 Main St, Bowdoin, ME, 04287-7302

    Description

    microTargeting" Drive System, Product Number MT-DS-01

    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.

    Action

    Urgent Medical Device Recall notification letters were sent to customers on 5/10/18. The letters included the following instructions: FHC, Inc. Field Representatives will review your inventory and replace effected Depth Stop Adapters you have on hand with an improved design. In the interim, we advise that you do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Inc. or your local field rep.

    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