microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Check against the official notice below — it lists the full affected range.
FHC, Inc. is recalling the microTargeting Lead Adapter for STar Drive (Product Number 70-CN-DB) 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, requiring patients to undergo intraoperative or follow-up procedures to have the implanted lead removed and replaced. A total of 2,952 devices were distributed across the United States, multiple foreign countries including Canada, Australia, and several European nations.
The affected devices have UDI 00873263002643 and were distributed to all U.S. states except Oklahoma and Wyoming, as well as to Argentina, Colombia, Denmark, Ecuador, France, Germany, and Great Britain. The source record does not specify a remedy or recommended course of action for affected consumers.
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: 00873263002643
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.