Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Reported: April 16, 2025 Initiated: March 4, 2025 #Z-1543-2025
Product Description
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 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.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators. Recalled by Medtronic Neuromodulation. Units affected: 1493 devices.
Why was this product recalled? ▼
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2025. Severity: Moderate. Recall number: Z-1543-2025.
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