FDA-Device2023-07-05Class II
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Medtronic Neuromodulation
Hazard
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
Sold states
Worldwide distribution.
Affected count
3791 devices
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief