FHC recalls microTargeting Drive System (MT-DS) due to depth stop adapter over-tightening risk. Damaged leads may require surgical removal. Product number: MT-DS, UDI: : 00873263003527.
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.
FHC is recalling its microTargeting Drive System (product number MT-DS) because the depth stop adapter can cause damage to the lead if over-tightened. This damage may lead to low impedances or short circuits, requiring surgical removal of the lead.
Over-tightening the depth stop screw onto the lead can damage the lead. This damage may cause low impedances or short circuits between electrode pairs, requiring surgical removal of the lead.
Medical professionals using the microTargeting Drive System for procedures are most at risk. Patients with implanted leads may need surgical intervention if the lead is damaged.
The product is the microTargeting Drive System with product number MT-DS. The unique device identifier (UDI) is 00873263003527.
Inspect the depth stop adapter for signs of over-tightening damage.
The depth stop adapter may cause damage to the lead if over-tightened, leading to low impedances or short circuits that require surgical removal.
The recall does not specify a remedy, so contact FHC directly for guidance.
The hazard requires surgical removal of the lead, which is a medical procedure, but the recall does not mention risk of serious injury to the user.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2345-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2345-2018 from FHC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
