Medtronic SynchroMed II — Class II medical device recall Z-0614-2024
Ongoing recall by Medtronic Neuromodulation, reported 2024-01-03. Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnet
| Recall number | Z-0614-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2023-11-13 |
| Classified | 2023-12-22 |
| Reported by FDA | 2024-01-03 |
| Quantity | 98,311 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00613994518781, 00643169100831, 00643169345188, 00643169345195, 00643169345201, 00643169384101, 00643169384118, 00643169384125, 00643169384132, 00643169384149, 00643169384156, 00643169384163, 00643169508149, 00643169530119, 00643169630505, 00643169700901, 00643169700918, 00643169700925, 00643169700932, 00643169700949, 00643169700956, 00643169700963, 00643169700970, 00643169700987, 00643169700994 and 55 more |
| Serial numbers | 11884H, 118H, 12943H, 174H, 409H, 434320H, 5227H, 5449H, 615226H, 61H, 691H, 734815H, 760160H, 760349H, 7762H, GP445488H, GP447797H, GP749251H, GP750435H, GP756525H, NGP000001H, NGP000004H, NGP000015H, NGP000016H, NGP000036H and 475 more |
| Model numbers | 8637-20 |
Product
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Reason for recall
Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
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-0614-2024. 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.