microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Check against the official notice below — it lists the full affected range.
The FHC microTargeting STar Drive System's Depth Stop Adapter has been recalled because over-tightening the depth stop screw can damage the lead and stylet. This damage may cause low impedances or short circuits between electrode pairs in the lead, potentially requiring patients to undergo a procedure to remove and replace the implanted lead. The affected devices were distributed across the United States, Canada, and several other countries.
A total of 2,952 devices with UDI numbers 00873263001486 and 00873263006351 were distributed. The recall record does not specify what actions affected consumers should take in response to this recall.
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: 00873263001486, 00873263006351
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.