Stimulation RC Clinician Programmer Application — Class II medical device recall Z-1543-2025
Ongoing recall by Medtronic Neuromodulation, reported 2025-04-16, distributed nationwide. There is a software issue that can permanently disable communication with an implantable neurostimulator (INS)
| Recall number | Z-1543-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2025-03-04 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CH, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, JP, LU, MT, NL, NO, PL, PT, SE, SI, SK, TR |
| Quantity | 1,493 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000371463 |
| Serial numbers | NPL1000037, NPL1000042, NPL1000053, NPL1000055, NPL1000056, NPL1000062, NPL1000067, NPL1000069, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000076, NPL1000098, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000160, NPL1000161, NPL1000165, NPL1000173, NPL1000174, NPL1000175, NPL1000179 and 475 more |
| Model numbers | 977118, 977119, A71400 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1543-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.