DBS recallZ-0217-2024 · Medtronic Neuromodulation · initiated May 27, 2022
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
FDA root cause category: Labeling Change Control
What the company is doing
Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail. The notice explained the issue, potential risk, and requested the return of the affected product.
Recall details
- Recall number
- Z-0217-2024
- Status
- Completed
- Initiated by the company
- May 27, 2022
- Posted by the FDA
- Nov 3, 2023
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 14 units
- Product code
- MHY
- FDA submissions
- P960009
- Distribution
- US: MO, FL, TX, WA
Product description
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Code information (models, lots, serial numbers)
UDI/DI 00763000274320, Serial Number VA2JV2V
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DBS™ 3387S-40Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms1 recall30 reports
Product lines
Other devices under the same FDA submission
89 devices cleared under P960009 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ACTIVA RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS2,839 reports
- Activa® RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 deaths1,849 reports
- ACTIVA PC 37601Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)15 deaths1,625 reports
- Activa® 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS1,325 reports
- Activa® 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR8 deaths1,093 reports
- Percept™ RC B35300Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms1 recall3 deaths796 reports
- Activa® 37602Medtronic, Inc. · Deep brain stimulator for obsessive compulsive disorder (OCD)1 recall6 deaths777 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Deep brain stimulator for obsessive compulsive disorder (OCD)4 recalls1 death547 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Stimulator, thalamic, epilepsy, implanted1 recall5 deaths543 reports
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Stimulator, thalamic, epilepsy, implanted1 recall478 reports
- Activa® PC 37601Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS3 deaths521 reports
- Activa® PC 37601Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 death502 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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