Medtronic Recalls DBS Therapy Kits Due to Potential Lead Damage
Medtronic is recalling DBS Therapy for Dystonia Kits because the provided lead cap may damage the lead connector, potentially compromising the device.
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 where injury has not yet been reported, but there is a risk of harm due to potential lead damage, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Neuromodulation is recalling Medtronic DBS Therapy for Dystonia Kits, models 3317, 3339, 3337, and 3339. The recall involves 30,000 units that were distributed worldwide, including in the United States and numerous international markets.
The recall is due to a potential for lead damage. Medtronic has received reports that the DBS leads were damaged at the connector end when the lead cap provided in the kits was used. The connector end is the part of the lead that connects to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and damage the lead.
Medtronic is providing additional instructions for capping the lead and removing the lead cap. The lead kits are not being removed from the market, but users should follow the new instructions to prevent damage.
The recalled product
- Product
- Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in
- Manufacturer
- Medtronic Neuromodulation
- 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 · 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
- 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
- SevereFHC Depth Stop Adapter Recall for Potential Lead Damage
FDA (Devices) · 2018-07-11