Reported Oct 23, 2024 · Ongoing

Vanta Implantable Neurostimulator (INS), Model 977006

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • Vanta Implantable Neurostimulator (INS), Model 977006
Lot codes and dates
  • UDI/DI 00763000411923
  • Serial Numbers

    2,714 of 2,714 codes

    • 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
    • NMS500364H
    • NMS500365H
    • NMS500366H
    • NMS500368H
    • NMS500369H
    • NMS500370H
    • NMS500371H
    • NMS500372H
    • NMS500373H
    • NMS500374H
Amount recalled
11789 units

Why it was recalled

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.