Medtronic MiniMed, Inc.
Medtronic MiniMed, Inc. appears in FDA public data with 81 recalls — including 4 Class I (most serious) —, 57 510(k) clearances, 14 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2698-2026, Class II) was initiated on May 27, 2026. Its most recent 510(k) clearance was granted on July 9, 2026.
Summary
- Total Recalls
- 81 (4 Class I)
- 510(k) Clearances
- 57
- Inspections
- 14
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2698-2026 | Class II | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | May 27, 2026 |
| Z-1740-2026 | Class II | MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | February 13, 2026 |
| Z-1750-2026 | Class II | Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) | February 13, 2026 |
| Z-1743-2026 | Class II | MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | February 13, 2026 |
| Z-1739-2026 | Class II | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) | February 13, 2026 |
| Z-1752-2026 | Class II | Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) | February 13, 2026 |
| Z-1749-2026 | Class II | Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) | February 13, 2026 |
| Z-1746-2026 | Class II | MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | February 13, 2026 |
| Z-1748-2026 | Class II | Paradigm Insulin Pump (MMT-712, MMT-715) | February 13, 2026 |
| Z-1742-2026 | Class II | MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) | February 13, 2026 |
| Z-1744-2026 | Class II | MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | February 13, 2026 |
| Z-1745-2026 | Class II | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) | February 13, 2026 |
| Z-1751-2026 | Class II | MiniMed 530G Insulin Pump (MMT-551, MMT-751) | February 13, 2026 |
| Z-1741-2026 | Class II | MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) | February 13, 2026 |
| Z-1747-2026 | Class II | MiniMed 620G Insulin Pump (MMT-1750) | February 13, 2026 |
| Z-1635-2026 | Class II | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 | January 30, 2026 |
| Z-0958-2026 | Class II | InPen App, Model/CFN Number: MMT-8061 (Android Users) | November 13, 2025 |
| Z-1238-2026 | Class II | MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The Mi | November 2, 2025 |
| Z-0594-2026 | Class II | CareLink Clinic, REF: MMT-7350 | October 21, 2025 |
| Z-2496-2025 | Class II | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | June 16, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | July 9, 2026 |
| K253743 | MiniMed Flex pump | March 12, 2026 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | February 3, 2026 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | January 15, 2026 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | January 14, 2026 |
| K253512 | MiniMed Go App | January 8, 2026 |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | August 29, 2025 |
| K251032 | MiniMed 780G insulin pump | July 1, 2025 |
| K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | November 12, 2024 |
| K241622 | Extended Reservoir; MiniMed Reservoir | July 2, 2024 |
| K210714 | Extended Reservoir | April 6, 2022 |
| K160860 | MiniMed Quick-serter | September 22, 2016 |
| K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Perso | May 19, 2015 |
| K120206 | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS | March 29, 2012 |
| K100432 | POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION S | July 9, 2010 |
| K073356 | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 | April 25, 2008 |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | October 17, 2007 |
| K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E | January 31, 2006 |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-8 | November 29, 2005 |
| K052432 | MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802 | November 29, 2005 |