FHC Depth Stop Adapter Recall for Potential Lead Damage
FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage implanted leads, 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 a medical device defect that has resulted in the need for surgical removal and replacement of implanted leads, meeting the criteria for significant injury or procedural risk.
Plain-English summary
FHC, Inc. is recalling the microTargeting Lead Adapter for STar Drive, Product Number 70-CN-DB. The recall involves 2,952 units of the device.
The recall was initiated because the FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as 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 intraoperatively or in a follow-up procedure.
The devices were distributed to numerous US states and foreign countries. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
- 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: 00873263002643
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
Same manufacturer · FHC, Inc.
See all →- SevereFHC microTargeting Insertion Tube Set Recalled for Spacer Defect
FDA (Devices) · 2024-11-20
- ModerateFHC Guideline 4000 5.0 Main Processing Unit Recalled for Electrical Defect
FDA (Devices) · 2020-07-15
- SevereFHC Depth Stop Adapter Recall Due to Lead Damage Risk
FDA (Devices) · 2018-07-11
- SevereFHC Depth Stop Adapter Recalled for Potential Lead Damage
FDA (Devices) · 2018-07-11
- SevereFHC Depth Stop Adapter Recalled for Potential Lead Damage
FDA (Devices) · 2018-07-11
Same hazard · lead damage
See all →- SevereFHC Depth Stop Adapter Recalled for Potential Lead Damage
FDA (Devices) · 2018-07-11
- SevereFHC Depth Stop Adapter Recalled for Potential Lead Damage
FDA (Devices) · 2018-07-11
- HighFHC Depth Stop Adapter Recall Due to Lead Damage Risk
FDA (Devices) · 2018-07-11
- SevereMedtronic Recalls DBS Therapy Kits Due to Potential Lead Damage
FDA (Devices) · 2013-05-08
Similar recalls
- SevereFHC microTargeting Insertion Tube Set Recalled for Spacer Defect
FDA (Devices) · 2024-11-20
- HighMedtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect
FDA (Devices) · 2017-08-30
- HighMicroport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty
FDA (Devices) · 2014-06-11
- ModerateMedtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue
FDA (Devices) · 2019-12-18
- HighSt. Jude Medical DBS Leads Recalled for Incorrect Electrode Material
FDA (Devices) · 2018-12-19
- SevereMedtronic HVAD Alarm Adapter Recalled for Potential Port Damage
FDA (Devices) · 2021-04-14