Synchromed II programmable pump — Class I medical device recall Z-0508-2020
Terminated recall by Medtronic Neuromodulation, reported 2019-12-11. There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfe
| Recall number | Z-0508-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2019-10-11 |
| Classified | 2019-12-03 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2023-09-15 |
| Countries outside the US | CA, CN |
| Quantity | 10,820 units |
| Serial numbers | NGP000003H, NGP000008H, NGP000009H, NGP000011H, NGP000013H, NGP000014H, NGP000017H, NGP000018H, NGP000019H, NGP000020H, NGP000023H, NGP000024H, NGP000026H, NGP000027H, NGP000029H, NGP000031H, NGP000032H, NGP000033H, NGP000034H, NGP000035H, NGP000036H, NGP000037H, NGP000038H, NGP000039H, NGP000040H and 475 more |
| Model numbers | 8637-20, 8637-40 |
Product
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Reason for recall
There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
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-0508-2020. 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.