microTargeting" Drive System, Product Number MT-DS
Check against the official notice below — it lists the full affected range.
FHC, Inc. is recalling 2,952 units of its microTargeting Drive System, model MT-DS, 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 led to the need for patients to undergo procedures to remove and replace the implanted lead, either during the initial surgery or in a follow-up procedure.
The affected devices were distributed across 44 U.S. states, as well as to Argentina, Australia, Canada, Colombia, Denmark, Ecuador, France, Germany, and Great Britain. The recalled devices carry UDI code 00873263003527. The source document does not specify what action affected consumers should take 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: 00873263003527
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.