# FDA recall Z-2036-2023

> **Medtronic Neuromodulation** · Class II · device recall initiated 2023-06-06.

## 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

- **Recall number:** Z-2036-2023
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-06
- **Report date:** 2023-07-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-2036-2023. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2036-2023. Source: US FDA. Licensed CC0.

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