Chrysalis Intelligence · Sponsors · Medtronic Minimed

Medtronic Minimed

Northridge, CA, US · 11 510(k) clearances · 129 PMAs · 55 recalls (3 Class I)

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Total clearances
11
2022-04-06 → 2026-07-09
Last 12 months
6
Product codes
4
Most recent
2026-07-09
Name variants in FDA filings: Medtronic Minimed / Medtronic MiniMed / Medtronic Minimed, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QJI Interoperable Automated Glycemic Controller Class II Clinical Chemistry 4 2026-07-09
QFG Alternate Controller Enabled Insulin Infusion Pump Class II Clinical Chemistry 3 2026-03-12
NDC Calculator, Drug Dose Class II Anesthesiology 2 2026-01-08
LZG Pump, Infusion, Insulin Class II General Hospital 2 2024-07-02
Class III

PMA approvals (129)

Total PMA records
129
Originals + supplements
Distinct product codes
6
First decision
2020-01-22
Most recent
2026-08-05
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-05 P160017-S139 MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2026-07-21 P250012-S011 Simplera Sync 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2026-07-21 P160017-S138 Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4S 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2026-07-21 P160007-S063 Simplera System; Simplera Sync 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2026-07-21 P150001-S111 Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2026-06-12 P250012-S008 Simplera Sync Sensor Real-Time Process SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2026-06-12 P160017-S135 MiniMed 780G System Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2026-06-12 P160007-S060 Simplera system Real-Time Process MDS Sensor, Glucose, Invasive Unknown
2026-05-26 P250012-S010 Simplera and Simplera Sync 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2026-05-26 P160017-S137 Simplera and Simplera Sync 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2026-05-26 P160007-S062 Simplera and Simplera Sync 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2026-03-19 P250012-S009 Simplera Sync Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2026-03-19 P160017-S136 Simplera Sync Sensor 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2026-01-23 P160007-S058 MiniMed Go app; Simplera sensor Real-Time Process MDS Sensor, Glucose, Invasive Unknown
2025-12-18 P160017-S133 MiniMed 670G System Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-12-11 P160017-S125 MiniMed 780G System Panel Track OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-12-10 P250012-S005 Simplera Sync Sensor; Guardian 4 Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-12-10 P160017-S131 MiniMed 670G system MiniMed 770G system MiniMed 780G system 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-12-08 P250012-S007 Simplera Sync Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-12-08 P160017-S134 MiniMed 780G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-12-08 P160007-S059 Simplera System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2025-12-05 P250012-S006 Simplera Sync Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-12-05 P160017-S132 MiniMed 780G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-12-05 P160007-S057 Simplera System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2025-10-16 P250012-S004 Simplera Sync Sensor, Guardian 4 Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-10-16 P160017-S130 MiniMed 670G System; MiniMed 770G System; MiniMed 780G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-10-16 P160007-S056 Guardian Connect System Simplera System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2025-10-16 P150001-S110 Medtronic MiniMed 630G System 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2025-10-09 P250012-S002 Guardian 4 Sensor Normal 180 Day Track No User Fee SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-10-09 P160017-S127 MiniMed 780G System Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-10-09 P160007-S054 Guardian Connect System Normal 180 Day Track No User Fee MDS Sensor, Glucose, Invasive Unknown
2025-10-02 P160017-S129 MiniMed 670G System Special (Immediate Track) OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-09-12 P250012-S003 Simplera Sync Sensor, Guardian 4 Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-09-12 P160017-S128 MiniMed 780G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-09-12 P160007-S055 Simplera System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2025-08-29 P160017-S124 MiniMed 780G System Panel Track OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-08-25 P250012-S001 Simplera Sync Sensor, Guardian 4 Sensor 30-Day Notice SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-08-25 P160017-S126 MiniMed 670G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-08-25 P160007-S053 Guardian Connect system 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2025-08-20 P160017-S122 MiniMed 770G System Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-08-06 P250012 Simplera Sync Sensor, Guardian 4 Sensor Original SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System Unknown
2025-05-09 P160017-S123 MiniMed 770G Insulin Pump; MiniMed 780G Insulin Pump Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2025-04-18 P160017-S118 MiniMed 780G System Panel Track OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-10-10 P160017-S121 MiniMed 780G System Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-10-07 P160017-S120 MiniMed 780G System Special (Immediate Track) OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-09-17 P160007-S052 Simplera (TM) System 30-Day Notice PQF Sensor, Glucose, Invasive, Non-Adjunctive Unknown
2024-07-24 P160007-S047 Simplera™ System Panel Track PQF Sensor, Glucose, Invasive, Non-Adjunctive Unknown
2024-07-17 P160017-S119 Guardian 4 Sensor 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-07-17 P160007-S051 Guardian 4 Sensor 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2024-04-19 P160017-S116 Medtronic MiniMed 780G insulin pump (MMT-1884), Medtronic MiniMed 780G insulin pump kit (MMT-1894) Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-03-21 P160017-S117 MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-01-05 P160017-S115 Guardian™ Sensor 3, Guardian™ 4 Sensor 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-01-05 P160007-S050 Guardian Sensor 3 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2024-01-05 P150001-S109 Guardian Sensor 3 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2024-01-03 P160017-S114 Guardian Sensor 3, Guardian 4 Sensor 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2024-01-03 P160007-S049 Guardian Sensor 3 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2024-01-03 P150001-S108 Guardian Sensor 3 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2023-10-30 P160017-S113 MiniMed 670G system, MiniMed 770G system and MiniMed 780G system Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-10-30 P150001-S107 MiniMed 630G system Real-Time Process OZO Automated Insulin Dosing , Threshold Suspend Unknown
2023-07-06 P160017-S111 Guardian 4 Sensor 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-06-15 P160017-S110 MiniMed 780G System Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-04-27 P160017-S093 MiniMed 770G System Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-04-21 P160017-S091 MiniMed 780G System Panel Track OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-04-18 P160017-S108 MiniMed 670G System Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-04-18 P150001-S104 MiniMed 630G System Real-Time Process OZO Automated Insulin Dosing , Threshold Suspend Unknown
2023-03-13 P160017-S109 Medtronic MiniMed 670G System (MM670G), Medtronic MiniMed 770G System (MM770G) 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2023-03-13 P150001-S105 Medtronic MiniMed 630G System (MM630G) 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-12-16 P160017-S106 MiniMed 670G System, MiniMedTM 770G System Special (Immediate Track) OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-12-16 P160017-S096 Guardian Sensor 3 135 Review Track For 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-12-16 P160007-S043 Guardian Sensor 3 135 Review Track For 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-12-16 P150001-S102 MiniMed 630G System Special (Immediate Track) OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-12-16 P150001-S094 Guardian Sensor 3 135 Review Track For 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-12-08 P160017-S105 Medtronic MiniMed 670G System, GS3 Transfer to MPROC, Medtronic MiniMed 770G System, Medtronic MiniMed 780G System 30-Day Notice — — —
2022-12-08 P160007-S046 Guardian Connect System 30-Day Notice — — —
2022-12-08 P150001-S101 MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-10-27 P160017-S103 MiniMed 770G Insulin Pump 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-10-17 P160017-S102 Medtronic MiniMed 670G System, Medtronic MiniMed 770G System Special (Immediate Track) OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-10-17 P150001-S099 Medtronic MiniMed 630G System with SmartGuard Special (Immediate Track) OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-04-29 P160017-S100 Guardian Sensor (3) (MMT-7020) 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-04-29 P160007-S044 Guardian Sensor (3) (MMT-7020) 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-04-29 P150029-S038 Enlite Sensor (MMT-7008) 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-04-29 P150019-S065 Enlite Sensor (MMT-7008) 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-04-29 P150001-S098 Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008) 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-04-28 P160017-S099 Medtronic MiniMed 670G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-04-28 P160017-S098 Medtronic MiniMed 670G insulin pump, Medtronic MiniMed 770G insulin pump 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2022-04-28 P150001-S097 Medtronic MiniMed 630G System 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2022-04-28 P150001-S096 Medtronic MiniMed 630G insulin pump 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2021-12-17 P160017-S095 MiniMed™ 670G System Special (Immediate Track) OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2021-12-17 P160007-S042 Guardian™ Connect system Special (Immediate Track) MDS Sensor, Glucose, Invasive Unknown
2021-12-17 P150029-S037 iPro™ 2 CGM System with Enlite™ Glucose Sensor Special (Immediate Track) MDS Sensor, Glucose, Invasive Unknown
2021-12-17 P150019-S064 Paradigm™ Real-Time Revel™ System Special (Immediate Track) MDS Sensor, Glucose, Invasive Unknown
2021-12-17 P150001-S093 MiniMed™ 630G System with SmartGuard™ Special (Immediate Track) OZO Automated Insulin Dosing , Threshold Suspend Unknown
2021-10-05 P160017-S094 MiniMed 670G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2021-10-05 P160007-S041 Guardian Connect System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2021-10-05 P150001-S092 MiniMed 630G System with SmartGuard Technology 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2021-07-07 P160017-S092 MiniMed 670G System, MiniMed 770G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2021-07-07 P150001-S091 MiniMed 630G System 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2021-04-19 P160017-S089 MiniMed 670G System, MiniMed 770G System Normal 180 Day Track No User Fee OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2021-02-25 P160017-S090 MiniMed 670G System and MiniMed 770G System Special (Immediate Track) OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2021-02-25 P160007-S040 Guardian Connect system Special (Immediate Track) MDS Sensor, Glucose, Invasive Unknown
2021-02-25 P150029-S036 iPro2 CGM System with Enlite Glucose Sensor Special (Immediate Track) MDS Sensor, Glucose, Invasive Unknown
2021-02-25 P150019-S063 Paradigm Real-Time Revel System Special (Immediate Track) MDS Sensor, Glucose, Invasive Unknown
2021-02-25 P150001-S090 MiniMed 630G System with SmartGuard Special (Immediate Track) OZO Automated Insulin Dosing , Threshold Suspend Unknown
2021-01-14 P160017-S083 miniMed 670G System 135 Review Track For 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2021-01-14 P160007-S035 Guardian Connect System 135 Review Track For 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2021-01-14 P150001-S084 MiniMed 630G System with Smart Guard 135 Review Track For 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-12-01 P160017-S088 MiniMed 670G System and MiniMed 770G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-12-01 P160007-S039 Guardian Connect system 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-12-01 P150029-S035 iPro2 CGM System with Enlite Sensor 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-12-01 P150019-S062 Paradigm Real-Time REVEL System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-12-01 P150001-S089 MiniMed 630G System 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-10-09 P160017-S087 MiniMed 670G System Real-Time Process OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-10-09 P150001-S088 MiniMed 630G System with SmartGuard Real-Time Process OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-09-02 P160017-S086 MiniMed 670G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-09-02 P160007-S037 Guardian Connect System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-09-02 P150001-S087 MiniMed 630G System 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-08-31 P160017-S076 MiniMed 770G System Panel Track OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-06-25 P160017-S085 MiniMed 670G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-06-25 P160007-S036 Guardian Connect System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-06-25 P150001-S086 MiniMed 630G System with Smart Guard 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-05-20 P160007-S029 Guardian Connect System Normal 180 Day Track MDS Sensor, Glucose, Invasive Unknown
2020-04-16 P160017-S082 MiniMed 670G Insulin Pump 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-04-16 P150001-S083 MiniMed 630G Insulin Pump 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-03-20 P160007-S032 Guardian Connect System Real-Time Process MDS Sensor, Glucose, Invasive Unknown
2020-01-31 P160017-S081 Medtronic MiniMed 670G System 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-01-31 P160007-S034 Guardian Connect System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-01-31 P150001-S082 Medtronic MiniMed 630G System 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
2020-01-22 P160017-S080 MiniMed 670G Insulin Pump 30-Day Notice OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown
2020-01-22 P150001-S081 MiniMed 630G Insulin Pump 30-Day Notice OZO Automated Insulin Dosing , Threshold Suspend Unknown
Safety

Recalls (55)

Class I (serious)
3
Risk of injury / death
Total recalls
55
Currently ongoing
55
Most recent
2026-07-13
DateSeverityStatusRecall # ProductCodeReason
2026-07-13 Class II Ongoing Z-2982-2026 MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW — Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result i…
2026-07-13 Class II Ongoing Z-2981-2026 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 case or keypad, allow moisture ingress, and result i…
2026-07-13 Class II Ongoing Z-2980-2026 MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; — Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result i…
2026-06-16 Class II Ongoing Z-2778-2026 MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) — For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the assoc…
2026-02-13 Class II Ongoing Z-1752-2026 Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) — 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 insul…
2026-02-13 Class II Ongoing Z-1751-2026 MiniMed 530G Insulin Pump (MMT-551, MMT-751) — 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 insul…
2026-02-13 Class II Ongoing Z-1750-2026 Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) — 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 insul…
2026-02-13 Class II Ongoing Z-1749-2026 Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) — 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 insul…
2026-02-13 Class II Ongoing Z-1748-2026 Paradigm Insulin Pump (MMT-712, MMT-715) — 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 insul…
2026-02-13 Class II Ongoing Z-1747-2026 MiniMed 620G Insulin Pump (MMT-1750) — 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 insul…
2026-02-13 Class II Ongoing Z-1746-2026 MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) — 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 insul…
2026-02-13 Class II Ongoing Z-1745-2026 MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) — 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 insul…
2026-02-13 Class II Ongoing Z-1744-2026 MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) — 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 insul…
2026-02-13 Class II Ongoing Z-1743-2026 MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) — 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 insul…
2026-02-13 Class II Ongoing Z-1742-2026 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 affected by unintended over- and under-delivery of insul…
2026-02-13 Class II Ongoing Z-1741-2026 MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) — 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 insul…
2026-02-13 Class II Ongoing Z-1740-2026 MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) — 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 insul…
2026-02-13 Class II Ongoing Z-1739-2026 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 affected by unintended over- and under-delivery of insul…
2026-01-30 Class II Ongoing Z-1635-2026 MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 — Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, …
2025-11-13 Class II Ongoing Z-0958-2026 InPen App, Model/CFN Number: MMT-8061 (Android Users) — When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to al…
2025-11-02 Class II Ongoing Z-1238-2026 MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin p… — A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspensi…
2025-10-21 Class II Ongoing Z-0594-2026 CareLink Clinic, REF: MMT-7350 — Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incor…
2025-06-16 Class II Ongoing Z-2496-2025 InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) — Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose rem…
2025-05-07 Class II Ongoing Z-0033-2026 Medtronic, Simplera Sensor, REF: MMT-5100JD1 — The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
2025-03-04 Class II Ongoing Z-1650-2025 InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA — Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge ho…
2025-01-31 Class II Ongoing Z-1266-2025 MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1265-2025 MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1264-2025 MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1263-2025 MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1262-2025 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 the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1261-2025 MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1260-2025 MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1259-2025 MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1258-2025 MiniMed insulin pump, REF: 620G (MMT-1750) — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1257-2025 Paradigm insulin pump, REF: MMT-754 — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1256-2025 Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751 — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2025-01-31 Class II Ongoing Z-1255-2025 Paradigm REF: MMT-712 and MMT-715 — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch…
2024-07-31 Class I Ongoing Z-0003-2025 MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MM… — Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump bat…
2024-07-31 Class I Ongoing Z-0002-2025 MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1… — Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump bat…
2024-07-31 Class I Ongoing Z-0001-2025 MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1… — Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump bat…
2023-11-15 Class II Ongoing Z-1005-2024 Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7… — Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor…
2022-11-21 Class II Ongoing Z-0776-2023 Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system — An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upl…
2022-09-20 Class II Ongoing Z-0194-2023 Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752 — Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow un…
2022-09-20 Class II Ongoing Z-0193-2023 Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760,… — Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow un…
2022-05-23 Class II Ongoing Z-1359-2022 MiniMed 780G Insulin Pump (O.U.S. Version) — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1358-2022 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 when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1357-2022 MiniMed 740G Insulin Pump (O.U.S. Version) — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1356-2022 MiniMed 720G Insulin Pump (O.U.S. Version) — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1355-2022 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 when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1354-2022 MiniMed 640G Insulin Pump (O.U.S. Version) — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1353-2022 MiniMed 630G Insulin Pump (U.S. and Canada Version) — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power…
2022-05-23 Class II Ongoing Z-1352-2022 MiniMed 620G Insulin Pump (O.U.S. version) — Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power…
2022-01-27 Class II Ongoing Z-0855-2022 MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, M… — New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must b…
2021-03-15 Class II Ongoing Z-1772-2021 MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PU… — Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user …
2021-03-15 Class II Ongoing Z-1771-2021 MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-18… — Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user …
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2026-07-09 K261962 SmartGuard Technology; Predictive Low Glucose Technology QJI Class II Clinical Chemistry
2026-03-12 K253743 MiniMed Flex pump QFG Class II Clinical Chemistry
2026-02-03 K253701 SmartGuard Technology; Predictive Low Glucose Technology QJI Class II Clinical Chemistry
2026-01-15 K253470 MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) QFG Class II Clinical Chemistry
2026-01-14 K253585 SmartGuard technology; Predictive Low Glucose technology QJI Class II Clinical Chemistry
2026-01-08 K253512 MiniMed Go App NDC Class II Anesthesiology
2025-08-29 K251217 SmartGuard technology; Predictive Low Glucose technology QJI Class II Clinical Chemistry
2025-07-01 K251032 MiniMed 780G insulin pump QFG Class II Clinical Chemistry
2024-11-12 K242775 InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) NDC Class II Anesthesiology
2024-07-02 K241622 Extended Reservoir; MiniMed Reservoir LZG Class II General Hospital
2022-04-06 K210714 Extended Reservoir LZG Class II General Hospital
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence