FHC recalls microTargeting Lead Adapter (Product 66-CN-DB) due to over-tightening causing lead damage and potential short circuits. Affected users should contact FHC for details.
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 a specific lead adapter for their microTargeting Drive system because over-tightening the depth stop screw can damage the lead. This damage may cause short circuits or require surgical removal of the implanted lead.
Over-tightening the depth stop screw on the adapter can damage the lead. This damage may cause low impedances or short circuits between electrode pairs, requiring surgical removal of the lead during procedures or follow-ups.
Medical professionals using the microTarget:ing Drive system with the recalled adapter are most at risk. Patients with implanted leads may need additional procedures if damage occurs.
Check for the product number 66-CN-DB on the adapter. The adapter is sold with FHC's microTargeting Drive system.
Reach out to FHC directly for specific instructions on the recalled adapter.
Over-tightening the depth stop screw can damage the lead, causing short circuits or requiring surgical removal of the implanted lead.
Contact FHC directly for specific instructions on the recalled adapter.
Yes, if the adapter is damaged, it may require surgical removal of the implanted lead during procedures or follow-ups.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2353-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2353-2018 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.
