FHC recalls microTargeting Lead Adapter (Product 70-CN-DB) due to over-tightening causing lead damage and potential need for 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 a specific lead adapter for their STar Drive system because over-tightening the depth stop screw can damage the lead. This damage may cause low impedances or short circuits, requiring surgical removal and replacement of the implanted lead.
Over-tightening the depth stop screw on the lead adapter can damage the medical lead. This damage may cause electrical issues like low impedances or short circuits between electrode pairs, which could require surgical intervention to fix.
Medical professionals using the FHC microTarget:ing Lead Adapter for STar Drive systems are affected. Patients with implanted leads are at risk if the adapter is damaged.
Check for the product number 70-CN-DB on the adapter. The adapter is sold with the STar Drive system and has a unique device identifier (UDI) starting with 00873263002643.
Inspect the depth stop screw for signs of over-tightening damage.
Reach out to FHC, Inc. for guidance on whether the adapter needs replacement.
The recall states that damage can require surgical removal and replacement of the implanted lead, but it does not specify if this causes serious injury in normal use.
Look for the product number 70-CN-DB on the adapter, which is sold with the STar Drive system and has a unique device identifier (UDI) starting with 00873263002643.
The recall does not specify a stop-use instruction; the remedy is null, so users should check for damage and contact FHC for guidance.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2354-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2354-2018 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.
