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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Medtronic Neuromodulation: Percept RC Implantable Neurostimulators Recalled for Communication Failure

Agency Publication Date: October 23, 2024
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Summary

Medtronic Neuromodulation is recalling 39 units of the Percept RC Implantable Neurostimulator (INS), Model B35300. This recall was initiated because these specific devices are unable to communicate with the A610 DBS Clinician Programmer Application during use. When doctors or clinicians attempt to program the device, they will receive an "Invalid Device" error message. Consumers with these implanted devices should contact their healthcare provider or Medtronic for further instructions regarding the device's functionality and potential next steps.

Risk

The device failure prevents medical professionals from communicating with or adjusting the neurostimulator's settings, which can lead to an inability to manage the patient's symptoms effectively. No injuries have been reported to date, but the communication error renders the device's specialized programming features inaccessible.

What You Should Do

  1. Check your device identification card or medical records to see if you have a Medtronic Percept RC Implantable Neurostimulator (INS), Model B35300.
  2. Verify if your device's Serial Number matches any of the following: NND504236H, NND504252H, 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, NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, or NND504228H.
  3. Contact your healthcare provider immediately if you have one of these affected serial numbers to discuss how this communication error affects your treatment and if a replacement is necessary.
  4. Contact Medtronic Neuromodulation at their headquarters (7000 Central Ave Ne, Minneapolis, MN 55432) or via their clinician support channels for further technical instructions regarding the 'Invalid Device' message.
  5. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Consultation with healthcare provider

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300 (GTIN 00763000813468)
Model / REF:
B35300
UPC Codes:
00763000813468
Lot Numbers:
NND504236H
NND504252H
Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300 (GTIN 00763000813475)
Model / REF:
B35300
UPC Codes:
00763000813475
Lot 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
Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300 (GTIN 00763000813529)
Model / REF:
B35300
UPC Codes:
00763000813529
Lot Numbers:
NND504167H
NND504178H
NND504179H
NND504180H
NND504182H
NND504227H
NND504228H
Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300 (GTIN A7630008135201)
Model / REF:
B35300
Lot Numbers:
NND504167H
NND504178H
NND504180H
Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300 (GTIN A7630008134701)
Model / REF:
B35300
Lot Numbers:
NND504181H
NND504243H

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95489
Status: Active
Manufacturer: Medtronic Neuromodulation
Sold By: Medtronic Neuromodulation; authorized medical distributors
Manufactured In: United States
Units Affected: 39 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.