microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
Check against the official notice below — it lists the full affected range.
FHC, Inc. is recalling the microTargeting STar Drive System (Manual), Product Number 70-ZD-MA, due to a hazard with the Depth Stop Adapter. When the depth stop screw is over-tightened onto the lead, it may damage the lead and stylet, causing low impedances or a short circuit 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 were distributed across all U.S. states and several foreign countries including Canada, Australia, Great Britain, Germany, France, Denmark, Argentina, Colombia, and Ecuador. The device can be identified by its UDI code 00873263002162. The source document does not specify a remedy or recommended 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: 00873263002162
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.