medical Class II Updated 2018-07-11

FHC, Inc. recalls microTargeting" STar" Drive System (Manual) Distributed by M

Recalled Product

microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

Hazard / Issue

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.

Issued by

FDA

Affected 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, WY

Lot/Code Info: UDI: 00873263001486, 00873263006351

View official government recall

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