FHC recalls microTargeting Drive System (Product 9033G060: Depth Stop Adapter may cause lead damage if over-tightened, 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 recalls its microTargeting Drive System with Product Number 9033G0601 due to a depth stop adapter that can damage the lead when over-tightened. This risk may require removing and replacing the implanted lead during surgery or follow-up procedures.
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.
Patients with the recalled microTargeting Drive System implanted devices are affected. Those with the depth stop adapter installed are at risk of lead damage.
The recalled product is the microTargeting Drive System with Product Number 9033G0601. It was distributed by Medtronic.
Look for Product Number 9033G0601 on the device.
The depth stop adapter may cause damage to the lead when over-tightened, leading to low impedances or short circuits that require lead replacement.
Check if your device has Product Number 9033G0601. If so, contact FHC for guidance on next steps.
The recall involves potential lead damage requiring surgical intervention, but the hazard does not cause immediate injury 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-2356-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2356-2018 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.
