microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
Check against the official notice below — it lists the full affected range.
The FHC Depth Stop Adapter, distributed by Medtronic as part of the microTargeting STar Drive System, may become damaged when its depth stop screw is over-tightened onto the lead and stylet. This damage can result in low impedances or short circuits between electrode pairs in the lead, necessitating removal and replacement of the implanted lead either during the initial surgery or in a follow-up procedure. A total of 2,952 devices were distributed across all U.S. states and several foreign countries including Canada, Australia, Argentina, and multiple European nations.
The source does not specify what action affected consumers should take.
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: 00873263006375, 00873263001493
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.