A820 myPTM Software Application associated with Medtronic SynchroMed… — Class II medical device recall Z-1506-2025
Ongoing recall by Medtronic Neuromodulation, reported 2025-04-09, distributed nationwide. Product complaints were received describing the A820 myPTM app taking longer than expected for patients to int
| Recall number | Z-1506-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2025-01-09 |
| Classified | 2025-04-01 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, GR, IE, IT, NL, NO, PT, SE |
| Quantity | 4,365 units |
| UPC / GTIN / UDI-DI | 00763000632793 |
Product
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Reason for recall
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
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-1506-2025. 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.