FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states that the defect has resulted in the need to remove and replace the implanted lead, which constitutes a significant injury or procedural complication.
Plain-English summary
FHC, Inc. is recalling the microTargeting STar Drive System (Manual), Product Number 70-ZD-MA, specifically the FHC Depth Stop Adapter. The recall involves 2,952 units distributed to 49 US states and the District of Columbia, as well as 17 foreign countries including Canada, Australia, and Germany.
The recall is issued because the 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. The source text notes that this issue has resulted in the need to remove and replace the implanted lead during intraoperative or follow-up procedures.
Healthcare providers and patients should contact FHC, Inc. for further instructions regarding the replacement or removal of the affected devices. The recall is classified as Class II by the FDA.
The recalled product
- Product
- microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
- Manufacturer
- FHC, Inc.
- Affected units
- 2,952
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00873263002162
Distribution
Part of a larger recall action
This product is one of 15 recalled by FHC, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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