FHC recalls microTargeting Drive System (MT-DS-01) due to depth stop adapter risk of lead damage causing short circuits. Affected patients may need lead replacement 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 their microTargeting Drive System (product number MT-DS-01) because the depth stop adapter can cause damage to the lead when over-tightened. This damage may lead to short circuits and require surgical removal and replacement of the implanted lead.
Over-tightening the depth stop screw on the lead can damage the lead, causing low impedances or short circuits between electrode pairs. This may require surgical removal and replacement of the implanted lead during follow-up procedures.
Patients with the microTargeting Drive System (product number MT-DS-01) who have the depth stop adapter are affected. Those with implanted leads are at highest risk.
Check for the microTargeting Drive System with product number MT-DS-01. The unique device identifier (UDI) is 00873263003503.
Inspect the lead for signs of damage such as low impedances or short circuits.
Discuss potential lead damage with your physician if you have symptoms or concerns.
The recall states that damage may require surgical removal and replacement of the implanted lead, but not all affected devices need this action.
Check for the microTargeting Drive System with product number MT-DS-01 and unique device identifier (UDI) 00873263003503.
The recall record does not specify a remedy, so no immediate fix is provided.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2346-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2346-2018 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.
