FHC recalls microTargeting Drive System (Product FC1006) due to depth stop adapter causing lead damage that may require surgical repair. Affected devices have specific UDI codes.
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 microTarget:ing Drive System (Product FC1006) because the depth stop adapter can cause damage to the implanted lead if over-tightened. This damage may require surgical removal and replacement of the lead during a procedure.
The depth stop adapter can cause damage to the lead if the depth stop screw is over-tightened. This damage may lead to low impedances or short circuits between electrode pairs, requiring surgical removal and replacement of the lead.
Patients with the recalled microTargeting Drive System (Product FC1006) are affected. Those with the depth stop adapter installed are at risk of lead damage requiring surgical repair.
Check for the product number FC1006 on the device. The unique device identifier (UDI) is 00873263001479. This system was distributed by Medtronic.
Look for product number FC1006 and UDI 00873263001479 on the device.
The depth stop adapter may cause damage to the lead if over-tightened, leading to low impedances or short circuits that require surgical repair.
Check your device for product number FC1006 and UDI 00873263001479. If affected, contact your healthcare provider for evaluation.
Damaged leads may require surgical removal and replacement during an in-office procedure.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2355-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2355-2018 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.
