microTargeting" Drive System, Product Number MT-DS-01
Check against the official notice below — it lists the full affected range.
FHC, Inc. is recalling the microTargeting Drive System (model MT-DS-01) because the Depth Stop Adapter may damage the lead and stylet when the depth stop screw is over-tightened. This damage can result in low impedances or short circuits between electrode pairs in the lead, requiring 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 00873263003503 were distributed across the United States (all 50 states plus Washington, D.C.), as well as to Argentina, Australia, Canada, Colombia, Denmark, Ecuador, France, Germany, and Great Britain.
The recall record does not specify what remedy or 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: 00873263003503
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.