Paradigm Insulin Pump — Class II medical device recall Z-1748-2026
Ongoing recall by Medtronic MiniMed, Inc., reported 2026-04-08, distributed nationwide. All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affect
| Recall number | Z-1748-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2026-02-13 |
| Classified | 2026-04-02 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BB, BD, BE, BG, BH, BM, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, KE, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 73,656 |
| UPC / GTIN / UDI-DI | 00613994151766, 00613994171344, 00613994171443, 00613994171528, 00613994171627, 00613994171917, 00613994172044, 00613994172129, 00613994172211, 00613994172334, 00613994172419, 00613994172525, 00613994172761, 00613994326478, 00613994326508, 00613994326539, 00613994326560, 00613994326584, 00613994326621, 00613994332929, 00613994394132, 00613994395696, 00613994395719, 00613994395726, 00613994395740 and 96 more |
Product
Paradigm Insulin Pump (MMT-712, MMT-715)
Reason for recall
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
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-1748-2026. 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.