FHC recalls microTargeting STar Drive System (Product 70-ZD-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 70-ZD-: The depth stop adapter can cause damage to the lead when over-tightened, potentially leading to short circuits or requiring surgical repair of the implanted lead.
The depth stop adapter may cause damage to the lead when over-tightened, which can lead to low impedances or short circuits between electrode pairs. This damage may require surgical removal and replacement of the implanted lead during follow-up procedures.
Patients who have received the microTargeting STar Drive System (Product Number 70-ZD-MA) from FHC, Inc. are most at risk, particularly those with implanted leads that could be damaged by over-tightening the depth stop screw.
Check for the product name 'microTargeting STar Drive System (Manual)' with Product Number 70-ZD-MA. The device has a unique device identifier (UDI) starting with 00873263002162.
Your doctor will determine if your device needs replacement due to potential lead damage.
The recall states that damage to the lead may require surgical removal and replacement of the implanted lead, but does not specify if this causes serious injury in normal use.
Check for the product name 'microTargeting STar Drive System (Manual)' with Product Number 70-ZD-MA and UDI starting with 00873263002162.
The recall does not specify a stop-use instruction; the remedy is not stated in the record.
We’ve drafted a message you can send FHC to request your refund or repair — edit it as you like.
Subject: Recall Z-2351-2018 — FHC FHC Hello, I own a FHC that is covered by recall Z-2351-2018 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.
