microTargeting" Drive System, Product Number 66-ZD-MD-01
Check against the official notice below — it lists the full affected range.
FHC, Inc. is recalling its microTargeting Drive System (Product Number 66-ZD-MD-01) because the Depth Stop Adapter may damage the lead and stylet when the depth stop screw is over-tightened. This damage can cause low impedances or short circuits between electrode pairs in the lead, resulting in the need to remove and replace the implanted lead during surgery or in a follow-up procedure. A total of 2,952 devices were affected and distributed across most U.S. states as well as several foreign countries including Canada, Australia, Argentina, and various European nations.
The source document does not specify what affected consumers should do 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: 00873263003565
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.