# FDA recall Z-1543-2025

> **Medtronic Neuromodulation** · Class II · device recall initiated 2025-03-04.

## Product

Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

## Reason for recall

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-1543-2025
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-04
- **Report date:** 2025-04-16

- **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-1543-2025

## Citation

> AI Analytics. FDA recall Z-1543-2025. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1543-2025. Source: US FDA. Licensed CC0.

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