FHC recalls Depth Stop Adapter model 66-AC-DS(1.8) due to over-tightening causing lead damage and short circuits, requiring lead replacement in surgery.
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 Depth Stop Adapter model 66-:AC-DS(1.8) because over-tightening the depth stop screw can damage the lead, leading to short circuits and requiring surgical lead replacement. This affects medical devices used during procedures involving implanted leads.
Over-tightening the depth stop screw onto the lead can cause damage to the lead, resulting in low impedances or short circuits between electrode pairs. This damage may require removing and replacing the implanted lead during surgery or follow-up procedures.
Medical professionals using the Depth Stop Adapter during procedures involving implanted leads. Those with the specific model number 66-AC-DS(1.8) are most at risk.
Check for the product model number 66-AC-DS(1.8) on the Depth Stop Adapter. The device has a unique identifier (UDI) starting with 00873263006375 or 00873263001493.
Verify the product model number on the Depth Stop Adapter to confirm it is 66-AC-DS(1.8).
Reach out to FHC, Inc. for guidance on next steps if the device is affected.
Over-tightening the depth stop screw can damage the lead, causing low impedances or short circuits that may require surgical lead replacement.
The recalled model is 66-AC-DS(1.8).
Check for the model number 66-AC-DS(1.8) or unique identifiers starting with 00873263006375 or 00873263001493.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2359-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2359-2018 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.
