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Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Recalled July 5, 2023 · FDA recall Z-2036-2023 · 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. · FDA Class II
Units
3791 devices
Sold at
Worldwide distribution.
Description
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.
Product
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →