# FDA recall Z-0206-2025

> **Medtronic Neuromodulation** · Class II · device recall initiated 2024-09-24.

## Product

Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

## Reason for recall

A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.

## Distribution

International distribution to the countries of Germany, UK, and Israel.

## Key facts

- **Recall number:** Z-0206-2025
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2024-10-30

- **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-0206-2025

## Citation

> AI Analytics. FDA recall Z-0206-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0206-2025. Source: US FDA. Licensed CC0.

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