Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm… — Class I medical device recall Z-1668-2013
Terminated recall by Medtronic MiniMed, reported 2013-07-17, distributed nationwide. Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm In
| Recall number | Z-1668-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Northridge, CA, United States |
| Recall initiated | 2013-06-07 |
| Classified | 2013-07-09 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2015-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BH, BM, BR, BS, CA, CH, CL, CN, CR, CY, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PY, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TT, TW, UA, UY, VE, ZA |
| Quantity | 11,000,000 units |
| Reason classes | device malfunction |
| Model numbers | MMT-312L, MMT-312S, MMT-317, MMT-318, MMT-324, MMT-325, MMT-368, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876 and 12 more |
Product
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Reason for recall
Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume 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-1668-2013. 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.