microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
Check against the official notice below — it lists the full affected range.
FHC, Inc. has recalled 2,952 Depth Stop Adapters (Model 66-AC-DS(1.8)) distributed across the United States, Argentina, Australia, Canada, Colombia, Denmark, Ecuador, France, Germany, and Great Britain. The adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened, potentially resulting in low impedances or short circuits between electrode pairs in the lead.
Patients implanted with affected devices have required removal and replacement of the lead either during the initial surgery or in a follow-up procedure. The source document 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: 00873263006375, 00873263001493
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.