microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
Check against the official notice below — it lists the full affected range.
FHC, Inc. is recalling the microTargeting STar Drive System (Motorized), Product Number 70-ZD-ME, specifically the Depth Stop Adapter component. The adapter may cause damage to the lead and stylet when its depth stop screw is over-tightened. This damage can result in low impedances or short circuits between one or multiple electrode pairs in the lead, requiring patients to undergo removal and replacement of the implanted lead either during surgery or in a follow-up procedure.
A total of 2,952 devices were distributed across the United States (all 50 states plus Washington, D.C.), as well as internationally to Argentina, Australia, Canada, Colombia, Denmark, Ecuador, France, Germany, and Great Britain. The product can be identified by UDI 00873263002155. The recall notice does not specify what affected consumers should do in response.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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, Quantity: 2952 total Lot/code info: UDI: 00873263002155
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.