Lower risk Medical device recall · FDA · Published September 24, 2024

Medtronic Percept RC Implantable Neurostimulators Model B35300: Communication Failure

Medtronic recalls 12 specific model B35300 implantable neurostimulators that fail to communicate with the A610 Clinician Programmer, showing an 'Invalid Device' message. Affected units have unique serial numbers and GTINs listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0206-2025Medical device Medtronic ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568

✎ GovInfoNow plain-language explainer

Medtronic is recalling a limited number of Percept RC Implantable Neurostimulators (Model B35300) because they cannot communicate with the A610 Clinician Programmer, displaying an 'Invalid Device' message. This issue may prevent proper device management and could lead to incorrect programming or device malfunction. Read more at govinfonow.com/recall/53878-medtronic-percept-rc-implantable-neurostimulators-model-b35300-communication-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/53878-medtronic-percept-rc-implantable-neurostimulators-model-b35300-communication-failure · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0206-2025

Cite this page

“Medtronic Percept RC Implantable Neurostimulators Model B35300: Communication Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53878-medtronic-percept-rc-implantable-neurostimulators-model-b35300-communication-failure. Based on FDA recall #Z-0206-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2025%22&limit=1).

The FDA announced on Sept. 24, 2024, that Medtronic Neuromodulation is recalling Model B35300 Percept RC Implantable Neurostimators because they may fail to communicate with the A610 DBS Clinician Programmer Application. The agency issued recall number Z-0206-2025 for the voluntary Class II action affecting 39 units distributed internationally.

How to tell if you have it

Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300
UPC 00763000813468, Serial Numbers: NND504236H, NND504252H
UPC 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
UPC 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H
GTIN A7630008135201, Serial Numbers: NND504167H, NND504178H, NND504180H
GTIN A7630008134701, Serial Numbers: NND504181H, NND504243H

The hazard

According to the FDA, a limited number of these devices will not be able to communicate with the A610 DBS Clinician Programmer Application upon use. An "Invalid Device" message will appear when users attempt to operate the system.

Context

GovInfoNow's records show Medtronic Neuromodulation has 45 other recalls on record since Aug. 9, 2017. Other recent recalls of similar products include Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (May 13, 2026) and Medtronic SynchroMed Flex Infusion Software Issue: Steps May Not Program Correctly (April 8, 2026). A Dec. 3, 2025 recall cited complaints that the Vanta A71200 CP App does not function as intended during use.

How to tell if you have this one

Check if your device has the model number B35300 and the specific serial numbers or GTINs listed in the recall. The affected units include 12 distinct serial numbers across multiple GTINs.

Brand
Medtronic
Product
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Verify your device model is B35300 and matches the serial numbers or GTINs listed in the recall.

How this recall unfolded

Recall timeline

FDA published this recall 36 days after the firm started it.

Sep 24, 2024Firm started the recall
Oct 23, 2024FDA classified it Class II
Oct 30, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53878-medtronic-percept-rc-implantable-neurostimulators-model-b35300-communication-failure">Medtronic Percept RC Implantable Neurostimulators Model B35300: Communication Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0206-2025 (September 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0206-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.