Medtronic Percept RC Implantable Neurostimulators (INS)… recallZ-0206-2025 · Medtronic Neuromodulation · initiated Sep 24, 2024
Class II Open, Classified All recalls posted in October 2024
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
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic neuromodulation issued an URGENT MEDICAL DEVICE RECALL notice to its consignees of 09/24/2024 via letter. The notice explained the issue, potential risk, and requested the affected devices in stock be returned. The notice is to be shared with those to whom the device was distributed. If the device has been implanted, the consignee was directed to contact their Medtronic Representative to determine if there are additional steps that may establish communication with the INS. On 07-Oct-24 and 08-Oct-24, a Medtronic representative successfully performed an update using a manufacturing software tool to reestablish communication to the affected devices. Consignees were provided a consignee notification regarding this action.
Recall details
- Recall number
- Z-0206-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 24, 2024
- Posted by the FDA
- Oct 23, 2024
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 39 units
- Product code
- MHY
- FDA submissions
- P960009
- Distribution
- International distribution to the countries of Germany, UK, and Israel.
Product description
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Code information (models, lots, serial numbers)
GTIN 00763000813468, Serial Numbers: NND504236H, NND504252H; GTIN 00763000813475, Serial Numbers: NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H; GTIN 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H; GTIN A7630008135201, Serial Numbers: NND504167H, NND504178H, NND504180H; GTIN A7630008134701, Serial Numbers: NND504181H, NND504243H
Other devices under the same FDA submission
90 devices cleared under P960009 — the recall does not name any of them by identifier. 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 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page