SynchroMed II implantable drug infusion pump — Class II medical device recall Z-1694-2017
Terminated recall by Medtronic Neuromodulation, reported 2017-04-05, distributed in IL. Medtronic received a complaint that there was an error code displayed on the programmer when the physician att
| Recall number | Z-1694-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2017-02-09 |
| Classified | 2017-03-29 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-09-04 |
| Distributed | IL |
| Quantity | 1 |
| Serial numbers | NGV526743H |
| Model numbers | 8637-40 |
Product
SynchroMed II implantable drug infusion pump, Model 8637-40,
Reason for recall
Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
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-1694-2017. 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.