FHC Depth Stop Adapter Recall Due to Lead Damage Risk
FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage the lead and stylet, potentially requiring surgical replacement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the hazard has resulted in the need for surgical intervention (removal and replacement of the implanted lead), which constitutes a risk of harm where injury has not been explicitly reported as a primary outcome but requires significant medical action.
Plain-English summary
FHC, Inc. is recalling 2,952 units of the microTargeting Lead Adapter for microTargeting Drive (Product Number 66-CN-DB). The recall is due to a risk that the depth stop screw may be over-tightened onto the lead, causing damage to the lead and stylet.
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 either intraoperatively or in a follow-up procedure.
The devices were distributed to numerous US states and foreign countries. Consumers and healthcare providers should contact FHC, Inc. for further instructions regarding the recall and potential replacement of the devices.
The recalled product
- Product
- microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
- 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: 00873263004531
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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