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Medtronic MiniMed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
65 (4 Class I)
510(k) Clearances
56
Inspections
14
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0958-2026Class IIInPen App, Model/CFN Number: MMT-8061 (Android Users)November 13, 2025
Z-1238-2026Class IIMiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiNovember 2, 2025
Z-0594-2026Class IICareLink Clinic, REF: MMT-7350October 21, 2025
Z-2496-2025Class IIInPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)June 16, 2025
Z-0033-2026Class IIMedtronic, Simplera Sensor, REF: MMT-5100JD1May 7, 2025
Z-1650-2025Class IIInPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGMarch 4, 2025
Z-1262-2025Class IIMiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)January 31, 2025
Z-1256-2025Class IIParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751January 31, 2025
Z-1264-2025Class IIMiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)January 31, 2025
Z-1257-2025Class IIParadigm insulin pump, REF: MMT-754January 31, 2025
Z-1261-2025Class IIMiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)January 31, 2025
Z-1260-2025Class IIMiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)January 31, 2025
Z-1266-2025Class IIMiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)January 31, 2025
Z-1259-2025Class IIMiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)January 31, 2025
Z-1265-2025Class IIMiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)January 31, 2025
Z-1258-2025Class IIMiniMed insulin pump, REF: 620G (MMT-1750)January 31, 2025
Z-1263-2025Class IIMiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)January 31, 2025
Z-1255-2025Class IIParadigm REF: MMT-712 and MMT-715January 31, 2025
Z-0003-2025Class IMiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMJuly 31, 2024
Z-0001-2025Class IMiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G InsuJuly 31, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K253743MiniMed Flex pumpMarch 12, 2026
K253701SmartGuard Technology; Predictive Low Glucose TechnologyFebruary 3, 2026
K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)January 15, 2026
K253585SmartGuard technology; Predictive Low Glucose technologyJanuary 14, 2026
K253512MiniMed Go AppJanuary 8, 2026
K251217SmartGuard technology; Predictive Low Glucose technologyAugust 29, 2025
K251032MiniMed 780G insulin pumpJuly 1, 2025
K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))November 12, 2024
K241622Extended Reservoir; MiniMed ReservoirJuly 2, 2024
K210714Extended ReservoirApril 6, 2022
K160860MiniMed Quick-serterSeptember 22, 2016
K151236MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink PersoMay 19, 2015
K120206MEDTRONIC MINIMED PARADIGM INSULIN PUMPSMarch 29, 2012
K100432POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SJuly 9, 2010
K073356PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715April 25, 2008
K070438MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305October 17, 2007
K053177MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712EJanuary 31, 2006
K052432MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802November 29, 2005
K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-8November 29, 2005
K043600MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407CMarch 29, 2005