Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL… — Class II medical device recall Z-0896-2018
Ongoing recall by Medtronic Neuromodulation, reported 2018-03-14, distributed nationwide. Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recall
| Recall number | Z-0896-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2017-08-09 |
| Classified | 2018-03-03 |
| Reported by FDA | 2018-03-14 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00643169508149, 00643169508156, 00643169700901, 00643169700918, 00643169700925, 00643169700932, 00643169700949, 00643169700956, 00643169700963, 00643169700970, 00643169700987, 00643169700994, 00643169701007, 00643169701014, 00643169701021, 00643169701038, 00643169701045, 00643169701052, 00643169701069, 00643169701076, 00643169701083, 00643169701090, 00643169732247, 00643169732254, 00643169732261 and 17 more |
| Model numbers | 8637 |
Product
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).
Reason for recall
Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
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-0896-2018. 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.