Medtronic MiniMed — Class II medical device recall Z-0107-2018
Ongoing recall by Medtronic Inc., reported 2017-11-29. Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
| Recall number | Z-0107-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2017-09-10 |
| Classified | 2017-11-18 |
| Reported by FDA | 2017-11-29 |
| Quantity | 3,971,030 units |
| Lot numbers | 5165412, 5170133, 5170134, 5170135, 5170153, 5170154, 5170155, 5170619, 5170622, 5170715, 5170823, 5170825, 5170827, 5170855, 5170856, 5170857, 5170858, 5170898, 5170901, 5170904, 5171629, 5171630, 5171631, 5171632, 5171633, 5171634, 5171635, 5171636, 5171637, 5171638, 5171639, 5171640, 5171641, 5171642, 5171643, 5171644, 5171645, 5171646, 5171647, 5171648 and 460 more |
Product
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
Reason for recall
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
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-0107-2018. 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.