microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
Check against the official notice below — it lists the full affected range.
Medtronic distributed approximately 2,952 FHC Depth Stop Adapters (product number FC1006) across the United States and several foreign countries. The adapter may cause damage to the lead and stylet when its depth stop screw is over-tightened, potentially resulting in low impedances or short circuits between electrode pairs in the lead. This damage has led to the need for patients to undergo surgery to remove and replace the affected implanted lead either during the initial procedure or in a follow-up operation.
The recalled devices were distributed throughout nearly all U.S. states and to countries including Canada, Australia, Great Britain, Germany, France, Denmark, Argentina, Colombia, and Ecuador. The product can be identified by UDI 00873263001479. The source document 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: 00873263001479
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.