SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable… — Class II medical device recall Z-0774-2025
Ongoing recall by Medtronic Neuromodulation, reported 2025-01-08, distributed nationwide. Software issues were identified in application version 2.x.
| Recall number | Z-0774-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2024-11-21 |
| Classified | 2024-12-27 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,981 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000447090, 00763000729141, 00763000737290 |
| Serial numbers | NPL3020725, NPL3021958, NPL3021963, NPL3021966, NPL3021969, NPL3021970, NPL3021971, NPL3021974, NPL3021983, NPL3021984, NPL3021990, NPL3021997, NPL3022002, NPL3022005, NPL3022014, NPL3022022, NPL3022031, NPL3022032, NPL3022038, NPL3022044, NPL3022052, NPL3022062, NPL3022069, NPL3022070, NPL3022071 and 475 more |
| Model numbers | 8637, 8667 |
Product
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Reason for recall
Software issues were identified in application version 2.x.
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-0774-2025. 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.