FHC recalls microTargeting Drive System (Product 66-ZD-MD) due to depth stop adapter over-tightening risking lead damage and requiring surgical repair.
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 their microTargeting Drive System (Product Number : 66-ZD-MD) because the depth stop adapter can cause damage to the lead if over-tightened. This damage may require surgical removal and replacement of the implanted lead during procedures.
Over-tightening the depth stop screw on the lead can damage the lead, causing low impedances or short circuits. This may require removing and replacing the implanted lead during surgery or follow-up procedures.
Medical professionals using the microTargeting Drive System for procedures are affected. Patients with implanted leads are at risk if the system is used improperly.
Check for the product number 66-ZD-MD on the microTargeting Drive System. The UDI code 00873263003572 is also associated with this recall.
Inspect the depth stop adapter for signs of over-tightening that might damage the lead.
Reach out to your medical provider to discuss potential lead damage and necessary procedures.
The depth stop adapter may cause damage to the lead if over-tightened, leading to low impedances or short circuits that require surgical repair.
Contact your medical provider to discuss potential lead damage and necessary procedures.
The recall does not specify a fix; medical providers may need to remove and replace the implanted lead if damage occurs.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2347-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2347-2018 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.
