# FDA recall Z-2657-2023

> **Medtronic Neuromodulation** · Class II · device recall initiated 2020-07-17.

## Product

Restore  Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

## Reason for recall

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

## Distribution

Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

## Key facts

- **Recall number:** Z-2657-2023
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-17
- **Report date:** 2023-10-11
- **Termination date:** 2024-09-27

- **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-2657-2023

## Citation

> AI Analytics. FDA recall Z-2657-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2657-2023. Source: US FDA. Licensed CC0.

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