FHC recalls microTargeting Drive System (Product 66-ZD-MD-01) due to depth stop adapter causing lead damage that may require surgical removal.
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 66-ZD-MD- 01) because the depth stop adapter can cause damage to the lead when 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, causing low impedances or short circuits. This may require surgical removal of the implanted lead during a procedure or follow-up.
Medical professionals who use the microTargeting Drive System for procedures are affected. Patients with implanted leads are at risk if the system is damaged.
The product is labeled as 'microTargeting Drive System' with Product Number 66-ZD-MD-01. It was sold with UDI: 00873263003565.
Inspect the depth stop adapter for signs of over-tightening damage.
The depth stop adapter may cause damage to the lead when over-tightened, leading to low impedances or short circuits that require surgical removal.
Check for damage to the depth stop adapter and contact FHC for guidance.
The hazard may require surgical removal of the implanted lead, but the recall does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2348-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2348-2018 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.
