# FDA recall Z-0418-2022

> **Medtronic Neuromodulation** · Class II · device recall initiated 2021-10-19.

## Product

Model B35200 - Percept PC BrainSense Implantable Neurostimulator

## Reason for recall

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

## Distribution

Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina, Brazil, Colombia, Thailand, and Hong Kong.

## Key facts

- **Recall number:** Z-0418-2022
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-19
- **Report date:** 2022-01-05

- **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-0418-2022

## Citation

> AI Analytics. FDA recall Z-0418-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0418-2022. Source: US FDA. Licensed CC0.

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