FHC, Inc. recalls microTargeting" Drive System, Product Number 66-ZD-MD-01

Recall date

May 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2348-2018

FDA classification

Class II

Brand / firm

FHC, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

microTargeting" Drive System, Product Number 66-ZD-MD-01