FHC recalls microTargeting STar Drive System (Motorized) due to depth stop adapter over-tightening risk. Damaged leads may require surgical removal. Product number ST-DS-ME.
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 (Motorized) because the depth stop adapter can cause damage to the lead if over-tightened. This damage may lead to low impedances or short circuits, requiring surgical removal of the lead.
The depth stop adapter can cause damage to the lead when the depth stop screw is over-tightened. This damage may create low impedances or short circuits between electrode pairs in the lead, potentially requiring surgical removal of the lead.
Medical professionals using the FHC microTargeting STar Drive System (Motorized) with Product Number ST-DS-ME are affected. Patients who have received this device may be at risk if the lead becomes damaged.
Check for the product name 'microTargeting STar Drive System (Motor: Motorized)' and product number ST-DS-ME. The device has a unique device identifier (UDI) starting with 00873263004432.
Verify if your device has the product number ST-DS-ME and UDI starting with 00873263004432.
The depth stop adapter may cause damage to the lead when over-tightened, potentially leading to low impedances or short circuits that require surgical lead removal.
Check if your device has product number ST-DS-ME and UDI starting with 00873263004432. Contact FHC for further instructions.
The recall involves potential lead damage requiring surgical removal, but the hazard does not cause immediate injury or death 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-2350-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2350-2018 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.
