FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the 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 a medical device defect that has resulted in the need for surgical procedures to remove and replace implanted leads, meeting the criteria for significant injury or procedural risk.
Plain-English summary
FHC, Inc. is recalling the microTargeting Drive System, Product Number FC1006, distributed by Medtronic. The recall involves 2,952 units of the FHC Depth Stop Adapter. The devices were distributed to numerous US states and foreign countries, including Argentina, Australia, Canada, and Germany.
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 result in low impedances or a short circuit between electrode pairs in the lead. Such damage has led to the need to remove and replace the implanted lead during the initial surgery or in a follow-up procedure.
Healthcare providers and patients should contact FHC, Inc. or Medtronic for instructions on how to manage the recalled devices and address any potential lead damage.
The recalled product
- Product
- microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
- Manufacturer
- FHC, Inc.
- Hazard
- 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: 00873263001479
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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