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Medtronic MiniMed

FDA Regulatory Profile

Summary

Total Recalls
80 (4 Class I)
510(k) Clearances
56
Inspections
14
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1746-2026Class IIMiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)February 13, 2026
Z-1751-2026Class IIMiniMed 530G Insulin Pump (MMT-551, MMT-751)February 13, 2026
Z-1745-2026Class IIMiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)February 13, 2026
Z-1742-2026Class IIMiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)February 13, 2026
Z-1743-2026Class IIMiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)February 13, 2026
Z-1740-2026Class IIMiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)February 13, 2026
Z-1744-2026Class IIMiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)February 13, 2026
Z-1752-2026Class IIParadigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)February 13, 2026
Z-1748-2026Class IIParadigm Insulin Pump (MMT-712, MMT-715)February 13, 2026
Z-1739-2026Class IIMiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)February 13, 2026
Z-1747-2026Class IIMiniMed 620G Insulin Pump (MMT-1750)February 13, 2026
Z-1749-2026Class IIParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)February 13, 2026
Z-1750-2026Class IIParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)February 13, 2026
Z-1741-2026Class IIMiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)February 13, 2026
Z-1635-2026Class IIMiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61January 30, 2026
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

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
K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-8November 29, 2005
K052432MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802November 29, 2005
K043600MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407CMarch 29, 2005