FHC Depth Stop Adapter Recall Due to Lead Damage Risk
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical 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 Severe because the source text explicitly states that the defect has resulted in the need to remove and replace the implanted lead, indicating significant injury and medical intervention.
Plain-English summary
FHC, Inc. is recalling the microTargeting STar Drive System (Motorized) Depth Stop Adapter, distributed by Medtronic. The recall involves 2,952 units of the device, identified by UDI codes 00873263006375 and 00873263001493.
The recall is issued because the Depth Stop Adapter may cause damage to the lead and stylet if the depth stop screw is over-tightened. This damage can result in low impedances or short circuits between 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.
The devices were distributed to numerous US states and foreign countries. Healthcare providers and patients should consult with their medical professionals regarding the use of this device and potential replacement options.
The recalled product
- Product
- microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
- 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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