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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/Surgical Equipment

Medtronic Neuromodulation: Vanta Implantable Neurostimulator Recalled for Premature Battery Depletion

Agency Publication Date: October 17, 2024
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Summary

Medtronic Neuromodulation is recalling approximately 11,789 Vanta Implantable Neurostimulators (Model 977006) because the batteries are draining faster than expected by healthcare providers and patients. This defect leads to the need for unexpected outpatient reprogramming or surgical replacement of the device earlier than anticipated. These devices were manufactured in the United States and distributed worldwide.

Risk

The premature loss of battery life causes the neurostimulator to stop providing therapy unexpectedly, requiring the patient to undergo additional surgical procedures for device replacement or frequent clinic visits for reprogramming.

What You Should Do

  1. Identify if you have the Vanta Implantable Neurostimulator Model 977006 by checking your patient ID card or contacting your healthcare provider.
  2. Check the serial number of your device against the affected list, which includes units with UDI/DI numbers 00763000411923, 00763000478087, 00763000754242, or 00763000849078.
  3. Contact your healthcare provider immediately to discuss your device's battery status and whether reprogramming or a surgical replacement is necessary.
  4. Monitor your device for any unusual behavior or loss of therapy and report these issues to your clinical team.
  5. Contact Medtronic Neuromodulation at their primary address (7000 Central Ave Ne, Minneapolis, MN 55432) or via their authorized support channels for further instructions.
  6. Call the FDA's recall information line at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Outpatient reprogramming or surgical replacement.

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

Affected Products

Product: Vanta Implantable Neurostimulator (INS)
Model / REF:
Model 977006
UPC Codes:
00763000411923
00763000478087
00763000518615
00763000754242
00763000849078
Lot Numbers (164):
NMS500122H
NMS500123H
NMS500130H
NMS500135H
NMS500159H
NMS500190H
NMS500191H
NMS500194H
NMS500201H
NMS500309H
NMS500310H
NMS500312H
NMS500313H
NMS500314H
NMS500315H
NMS500316H
NMS500317H
NMS500318H
NMS500319H
NMS500320H
NMS500321H
NMS500322H
NMS500323H
NMS500326H
NMS500327H
NMS500329H
NMS500330H
NMS500332H
NMS500333H
NMS500334H
NMS500335H
NMS500336H
NMS500337H
NMS500339H
NMS500340H
NMS500341H
NMS500343H
NMS500344H
NMS500345H
NMS500347H
NMS500348H
NMS500350H
NMS500351H
NMS500356H
NMS500357H
NMS500358H
NMS500359H
NMS500360H
NMS500361H
NMS500363H

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95281
Status: Active
Manufacturer: Medtronic Neuromodulation
Sold By: authorized healthcare providers
Manufactured In: United States
Units Affected: 11789 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.