Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk
Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.
What this means for you
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 involves a medical device with a risk of harm (lead damage) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic Neuromodulation is recalling 30,000 units of the Medtronic DBS Lead Kit for Deep Brain Stimulation, including models 3387, 3387S, 3389, 3389S, 3391, and 3391S. The affected products are sterile and non-pyrogenic and are indicated for the treatment of Dystonia, Essential Tremor, Obsessive-Compulsive Disorder, Parkinson’s Disease, and epilepsy.
The recall is due to a potential for lead damage at the connector end when the provided lead cap is used. Medtronic has received reports that tightening or loosening the setscrew may twist the setscrew connector block, which can damage the lead. The connector end is the part of the lead that connects to the lead extension.
The affected products were distributed worldwide, including in the United States and numerous international markets. Medtronic is not removing the lead kits from the market; instead, the company is providing additional instructions for capping the lead and removing the lead cap to address the issue.
The recalled product
- Product
- Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dyston
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 30,000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Neuromodulation 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 2 products in this recall →Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
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