Medtronic SynchroMed II Implantable Infusion Pumps — Class II medical device recall Z-1681-2015
Terminated recall by Medtronic Neuromodulation, reported 2015-06-03, distributed nationwide. Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable d
| Recall number | Z-1681-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2015-04-10 |
| Classified | 2015-05-27 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2015-11-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, CH, DE, ES, FR, GB, IE, IT, JP, KR, LU, MT, NL, NO, PA, PL, PT, SA |
| Serial numbers | NGP410145H, NGP410146H, NGP410147H, NGP410148H, NGP410149H, NGP410150H, NGP410151H, NGP410152H, NGP410153H, NGP410155H, NGP410156H, NGP410157H, NGP410158H, NGP410159H, NGP410160H, NGP410162H, NGP410163H, NGP410165H, NGP410166H, NGP410168H, NGP410169H, NGP410171H, NGP410174H, NGP410175H, NGP410177H and 475 more |
| Model numbers | 8637-20, 8637-40 |
Product
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter
Reason for recall
Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
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-1681-2015. 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.