08
Apr
2025

FDA Recall: Software issue that can permanently disable communication with an implantable neurostimulator

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Company: Medtronic Neuromodulation
Date of Enforcement Report: 4/8/2025
Class II

PRODUCT

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

Recall Number:

Z-1543-2025

REASON:

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

RECALLING FIRM/MANUFACTURER:

Medtronic Neuromodulation

VOLUME:

1493 devices

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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