FHC Depth Stop Adapter Recall for Lead Damage Risk
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, 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 3/5 (High).
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 is classified as FDA Class II. The hazard involves a risk of harm (lead damage requiring surgical replacement) where injury has not been explicitly reported as a direct adverse event, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
FHC, Inc. is recalling the microTargeting STar Drive System (Manual), Product Number FC8001, distributed by Medtronic. The recall involves 2,952 units of the device.
The recall is due to a defect in the FHC Depth Stop Adapter. If the depth stop screw is over-tightened onto the lead, it may cause damage to the lead and stylet. This damage can result in low impedances or a short circuit between electrode pairs, which has led to the need for the implanted lead to be removed and replaced during the initial surgery or in a follow-up procedure.
The devices were distributed to 48 US states and the District of Columbia, as well as 17 foreign countries including Argentina, Australia, Canada, and Japan. Healthcare providers and patients should contact FHC, Inc. or Medtronic for instructions on how to address the defect and manage affected leads.
The recalled product
- Product
- microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
- 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: 00873263001486
- 00873263006351
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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