Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vanta with AdaptiveStim Implantable Neurostimulator Recalled by Medtronic Neuromodulation Due to A cardioversion procedure may damage the electronics in...

Date: June 6, 2023
Company: Medtronic Neuromodulation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.

Affected Products

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

Quantity: 3791 devices

Why Was This Recalled?

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.

Where Was This Sold?

Worldwide distribution.

About Medtronic Neuromodulation

Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report