FHC recalls motorized microTargeting STar Drive System (Product 70-ZD-ME) due to depth stop adapter risk of lead damage causing short circuits or 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 its microTargeting STar Drive System (Product Number 70-Z:ME) because the depth stop adapter can cause damage to the lead when over-tightened. This damage may lead to short circuits or require surgical removal of the implanted lead.
The depth stop adapter can cause damage to the lead when over-tightened. This damage may result in low impedances or short circuits between electrode pairs, requiring surgical removal of the implanted lead.
Patients who have received the microTargeting STar Drive System (Product Number 70-ZD-ME) from FHC, Inc. are most at risk. This device is used in medical procedures involving implanted leads.
Check for the product name 'microTargeting STar Drive System (Motorized)' with Product Number 70-ZD-ME. The device was sold with a unique device identifier (UDI) starting with 00873263002155.
Verify if your device has Product Number 70-ZD-ME and UDI starting with 00873263002155.
The depth stop adapter may cause damage to the lead when over-tightened, leading to short circuits or requiring surgical removal of the implanted lead.
The recall record does not specify a remedy or action steps for affected users.
The recall indicates the risk may require surgical removal of the implanted lead, but does not specify injury risk in normal use.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2352-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2352-2018 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.
