# FDA recall Z-1368-2021

> **Medtronic Neuromodulation** · Class II · device recall initiated 2021-03-09.

## Product

A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and  3.0.1057*  * Version 3.0.1057 is approved for distribution in Europe only.

## Reason for recall

There are two issues within this correction action:  1. Cycling Issue:  When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly.  2. Log Fill Issue:  When the Percept PC INS System Event log is full, the  clinician programmer A610 Software application version  2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.

## Distribution

Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-1368-2021
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-09
- **Report date:** 2021-04-14

- **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-1368-2021

## Citation

> AI Analytics. FDA recall Z-1368-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1368-2021. Source: US FDA. Licensed CC0.

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