microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
Check against the official notice below — it lists the full affected range.
FHC, Inc. has recalled the microTargeting STar Drive System (Motorized), Product Number ST-DS-ME, due to a hazard involving the Depth Stop Adapter. When the depth stop screw is over-tightened onto the lead, it may damage the lead and stylet, potentially causing low impedances or short circuits between electrode pairs. This damage has required patients to undergo procedures to remove and replace the implanted lead either during surgery or in a follow-up procedure. A total of 2,952 devices with UDI 00873263004432 were distributed across all U.S. states and several foreign countries including Canada, Australia, Great Britain, Germany, France, Argentina, and others.
The recall 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: 00873263004432
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.