FHC Depth Stop Adapter Recalled for Potential Lead Damage
FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.
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 the source text explicitly states that the defect has resulted in the need to remove and replace the implanted lead, which constitutes a significant injury or procedural complication.
Plain-English summary
FHC, Inc. is recalling the microTargeting STar Drive System (Manual), Product Number ST-DS-MA. The recall involves 2,952 units that were distributed to 48 U.S. states and 17 foreign countries.
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 in the lead.
The source text states that this damage has resulted in the need to remove and replace the implanted lead during the initial operation or in a follow-up procedure. The recall is classified as Class II by the FDA.
The recalled product
- Product
- microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
- 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: 00873263004418
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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