Z-0206-2025Class II

Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300

Name: Z-0206-2025 Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300
Creator: Medtronic Neuromodulation
Published: 2024-09-24
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2024-09-24 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300 on 2024-09-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0206-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-24
Posted: 2024-10-23
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 39 units
Distribution: International distribution to the countries of Germany, UK, and Israel.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)