FHC microTargeting Drive System Recalled for Lead Damage Risk
FHC, Inc. is recalling 2,952 microTargeting Drive Systems 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 significant injury reports, specifically the need to remove and replace implanted leads due to damage.
Plain-English summary
FHC, Inc. is recalling 2,952 units of the microTargeting Drive System, Product Number MT-DS. The recall is due to a risk that 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 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 either intraoperatively or in a follow-up procedure.
The devices were distributed to numerous US states and foreign countries, including Argentina, Australia, Canada, and Germany. The source text does not provide specific instructions for consumers or patients on how to respond to this recall.
The recalled product
- Product
- microTargeting" Drive System, Product Number MT-DS
- 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: 00873263003527
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 · device damage
See all →- HighRENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
FDA (Devices) · 2024-04-24
- SevereNimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
FDA (Devices) · 2024-04-03
- HighBaxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
FDA (Devices) · 2022-02-16
- HighCorin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21
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
- HighMedtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment
FDA (Devices) · 2014-08-06
- HighMedtronic Recalls DBS Lead Kits Due to Potential Insulation Damage
FDA (Devices) · 2016-08-31
- ModerateMedtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue
FDA (Devices) · 2019-12-18
- HighSynthes Dynamic Locking Screw System Recalled for Pin Breakage
FDA (Devices) · 2015-09-30