FDA recall Z-2036-2023

Product

Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

Reason for recall

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-06-06

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2023