FHC recalls microTargeting STar Drive System (Manual) with Product Number FC8001 due to risk of lead damage from over-tightening depth stop screw, requiring lead replacement.
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 (Manual) with Product Number FC8001 because over-tightening the depth stop screw can damage the lead, potentially causing short circuits that require surgical lead replacement. This risk affects patients with implanted devices and could lead to additional procedures.
Over-tightening the depth stop screw on the lead can cause damage to the lead, leading to low impedances or short circuits between electrode pairs. This may require removing and replacing the implanted lead during surgery or a follow-up procedure.
Patients with the recalled microTargeting STar Drive System (Manual) who have an implanted device are most at risk. The device is used for medical procedures involving implanted leads.
Check for Product Number FC8001 on the device. The system was distributed by Medtronic and sold with UDI numbers 00873263001486 or 00873263006351.
Look for Product Number FC8001 on the device or UDI numbers 00873263001486 or 00873263006351.
Over-tightening the depth stop screw can damage the lead, causing low impedances or short circuits that may require surgical lead replacement.
Check if your device has Product Number FC8001 or UDI numbers 00873263001486 or 00873263006351. Contact FHC for guidance.
The recall does not specify a fix; the remedy is null, meaning no action is required beyond checking the device.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2357-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2357-2018 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.
