[pending] Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 97
Pending LLM rewrite. Source: FDA_DEVICE Z-1543-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
The recalled product
- Product
- Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00763000371463
Distribution
Distributed nationwide across the United States.
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