# FDA recall Z-0612-2021

> **Medtronic Neuromodulation** · Class II · device recall initiated 2020-11-19.

## Product

Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

## Reason for recall

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

## Distribution

US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.

## Key facts

- **Recall number:** Z-0612-2021
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-19
- **Report date:** 2020-12-23
- **Termination date:** 2023-04-03

- **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-0612-2021

## Citation

> AI Analytics. FDA recall Z-0612-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0612-2021. Source: US FDA. Licensed CC0.

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