FDA-Device2024-10-23Class II
Vanta Implantable Neurostimulator (INS), Model 977006
Medtronic Neuromodulation
Hazard
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Sold states
Worldwide distribution.
Affected count
11789 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Vanta Implantable Neurostimulator (INS), Model 977006
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2025Don't want to check this manually?
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