FHC microTargeting Drive System Recalled for Lead Damage Risk
FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring 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 damage.
Plain-English summary
FHC, Inc. is recalling 2,952 units of the microTargeting Drive System, Product Number MT-DS. The recall is due to a risk that the Depth Stop Adapter may cause damage to the lead and stylet if 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 either intraoperatively or in a follow-up procedure.
The devices were distributed to numerous US states and foreign countries, including Argentina, Australia, Canada, and Germany. The source text does not provide specific instructions for consumers or patients on how to respond to this recall.
The recalled product
- Product
- microTargeting" Drive System, Product Number MT-DS
- 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: 00873263003527
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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