FHC recalls microTargeting STar Drive System (Product Number ST-DS-MA) due to depth stop adapter risk of lead damage causing short circuits or requiring 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 ST-DB-MA) 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.
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 of the implanted lead during the procedure or follow-up.
Medical professionals using the microTargeting STar Drive System for procedures are affected. Patients with implanted leads are at risk if the system causes damage during use.
Check for the product name 'microTargeting STar Drive System (Manual)' with Product Number ST-DS-MA. The UDI is 00873263004418.
Inspect the depth stop adapter for signs of over-tightening damage.
Reach out to FHC, Inc. for guidance on lead replacement if damage is suspected.
The recall may require surgical removal of the implanted lead, but the hazard itself does not cause direct injury.
Look for the product name 'microTargeting STar Drive System (Manual)' with Product Number ST-DS-MA and UDI 00873263004418.
No immediate stop is required; check for damage and contact FHC if concerns arise.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2349-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2349-2018 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.
