FHC Depth Stop Adapter Recalled for Lead and Stylet Damage
FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.
What this means for you
Illness, injury, or structural failure has been reported. 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 device damage.
Plain-English summary
FHC, Inc. is recalling the microTargeting Drive System, Product Number MT-DS-01, specifically the FHC Depth Stop Adapter component. The recall involves 2,952 units distributed to numerous US states and foreign countries, including Argentina, Australia, Canada, and Germany.
The recall is issued because the 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 states that this damage has resulted in the need to remove and replace the implanted lead during intraoperative or follow-up procedures.
Healthcare providers and patients should check their inventory or medical records for the affected product. If the device is in use, clinicians should monitor for signs of lead damage, such as low impedances or short circuits, and consult the manufacturer for replacement instructions.
The recalled product
- Product
- microTargeting" Drive System, Product Number MT-DS-01
- 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: 00873263003503
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