Automated Insulin Dosing Device System, Single Hormonal Control
FDA product code OZP · Class III (high risk) · Clinical Chemistry
An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
0510(k) clearances
1PMA approvals
23recalls
PMA approvals
- P160017 MiniMed 670G System · Medtronic Minimed, Inc. · 09/28/2016
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2981-2026 Class II | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | Medtronic MiniMed, Inc. | 07/13/2026Open, Classified |
| Z-1742-2026 Class II | MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be… | Medtronic MiniMed, Inc. | 02/13/2026Open, Classified |
| Z-1739-2026 Class II | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be… | Medtronic MiniMed, Inc. | 02/13/2026Open, Classified |
| Z-1238-2026 Class II | MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60…A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump… | Medtronic MiniMed, Inc. | 11/02/2025Open, Classified |
| Z-1266-2025 Class II | MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895…All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have… | Medtronic MiniMed, Inc. | 01/31/2025Open, Classified |
| Z-1265-2025 Class II | MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891…All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have… | Medtronic MiniMed, Inc. | 01/31/2025Open, Classified |
| Z-1262-2025 Class II | MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have… | Medtronic MiniMed, Inc. | 01/31/2025Open, Classified |
| Z-1261-2025 Class II | MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781…All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have… | Medtronic MiniMed, Inc. | 01/31/2025Open, Classified |
| Z-0003-2025 Class I | MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780…Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal… | Medtronic MiniMed, Inc. | 07/31/2024Open, Classified |
| Z-1005-2024 Class II | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3…Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A… | Medtronic MiniMed, Inc. | 11/15/2023Open, Classified |
| Z-0193-2023 Class II | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780…Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated… | Medtronic MiniMed | 09/20/2022Open, Classified |
| Z-1359-2022 Class II | MiniMed 780G Insulin Pump (O.U.S. Version)Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to… | Medtronic MiniMed | 05/23/2022Open, Classified |
| Z-1358-2022 Class II | MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to… | Medtronic MiniMed | 05/23/2022Open, Classified |
| Z-1355-2022 Class II | MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to… | Medtronic MiniMed | 05/23/2022Open, Classified |
| Z-0855-2022 Class II | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742…New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus… | Medtronic MiniMed | 01/27/2022Open, Classified |
| Z-1772-2021 Class II | MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN; PUMP MMT-1740KX…Due to a software design issue, under certain conditions, a software fault is detected when a large bolus… | Medtronic Minimed | 03/15/2021Open, Classified |
| Z-1771-2021 Class II | MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886…Due to a software design issue, under certain conditions, a software fault is detected when a large bolus… | Medtronic Minimed | 03/15/2021Open, Classified |
| Z-0516-2021 Class II | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product…Missing solder battery connection, which could interrupt power of insulin pump. | Medtronic Inc. | 04/30/2020Open, Classified |
| Z-0958-2020 Class I | Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711…There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The… | Medtronic Inc. | 11/21/2019Open, Classified |
| Z-0957-2020 Class I | Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and…There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The… | Medtronic Inc. | 11/21/2019Open, Classified |
| Z-0956-2020 Class I | Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741…There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The… | Medtronic Inc. | 11/21/2019Open, Classified |
| Z-2605-2017 Class II | MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck… | Medtronic Inc. | 05/08/2017Terminated |
| Z-2604-2017 Class II | MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712…Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck… | Medtronic Inc. | 05/08/2017Terminated |