FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 the Depth Stop Adapter, which is used with the microTargeting STar Drive System (Motorized), Product Number 70-ZD-ME. The recall involves 2,952 units of the adapter.
The recall is being issued because 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 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 during intraoperative or follow-up procedures.
The devices were distributed to numerous US states and foreign countries. Consumers and healthcare providers should contact FHC, Inc. for instructions on how to handle the recalled adapters and manage affected leads.
The recalled product
- Product
- microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
- 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: 00873263002155
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.
See all 15 products in this recall →Related recalls
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