FDA Device recall Z-1506-2025
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System by Medtronic Neuromodulation, citing product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1506-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-09 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Reason
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Identifiers
| code_info | version v.2x, UDI/DI 00763000632793 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1506-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.