FHC Depth Stop Adapter Recalled for Lead Damage Risk
FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, 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 involves significant injury reports, specifically the need to remove and replace implanted leads due to device damage.
Plain-English summary
FHC, Inc. is recalling the microtargeting Depth Stop Adapter, Product Number 66-AC-DS(1.8). The recall involves 2,952 units that were distributed to 46 U.S. states and 17 foreign countries.
The device 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 issue has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure.
Healthcare professionals and patients should contact FHC, Inc. for further instructions regarding the recall and replacement of the affected devices.
The recalled product
- Product
- microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
- 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 (2)
- UDI: 00873263006375
- 00873263001493
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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