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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

Medtronic Neuromodulation: Restore Clinician Programmer Software Recalled for Communication Failure

Agency Publication Date: September 29, 2023
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Summary

Medtronic Neuromodulation has recalled 2,408 units of its Restore Clinician Programmer Application Software, model number A71100. The software, specifically version 1.0.4232, has a compatibility issue with older programmer systems that prevents it from communicating with implanted neurostimulators. This failure to connect means healthcare providers may be unable to adjust or monitor a patient's implanted device as intended. This software was distributed nationwide in the United States and internationally to Australia and Singapore.

Risk

The software cannot establish a connection with the implanted neurostimulator device due to compatibility errors with legacy systems. This prevents clinicians from programming or adjusting the patient's therapy, which could lead to a loss of symptom control or the inability to address device issues.

What You Should Do

  1. Identify if your clinician's office uses the Restore Clinician Programmer Application Software, model number A71100, version 1.0.4232 (UDI-DI 00763000273668).
  2. Contact your healthcare provider or clinician to confirm if your specific implanted neurostimulator is affected by this communication compatibility issue.
  3. If you have an implanted Restore Neurostimulator and your clinician cannot establish a connection with the device, contact Medtronic Neuromodulation directly at 1-800-328-2517 for technical assistance and further instructions.
  4. For additional information regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Compatibility issue resolution

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

Affected Products

Product: Restore Clinician Programmer Application Software
Model / REF:
A71100
Lot Numbers:
Version 1.0.4232
UDI-DI 00763000273668

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92798
Status: Resolved
Manufacturer: Medtronic Neuromodulation
Sold By: Government distribution; Military distribution; Direct to hospitals and clinics
Manufactured In: United States
Units Affected: 2,408 devices
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.