Recall Register

Medtronic MiniMed, Inc.: FDA recalls

FDA enforcement reports name Medtronic MiniMed, Inc. as the recalling firm in 23 events. The events have 52 product records. The recalls started from 2014 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

23 events, newest first.

FDA enforcement events of Medtronic MiniMed, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
13 Jul 2026MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;DeviceClass II3Ongoing
16 Jun 2026MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)DeviceClass II1Ongoing
27 May 2026MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896DeviceClass II1Ongoing
13 Feb 2026MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)DeviceClass II14Ongoing
30 Jan 2026MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61DeviceClass II1Ongoing
13 Nov 2025InPen App, Model/CFN Number: MMT-8061 (Android Users)DeviceClass II1Ongoing
2 Nov 2025MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal…DeviceClass II1Ongoing
21 Oct 2025CareLink Clinic, REF: MMT-7350DeviceClass II1Ongoing
16 Jun 2025InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)DeviceClass II1Ongoing
7 May 2025Medtronic, Simplera Sensor, REF: MMT-5100JD1DeviceClass II1Ongoing
4 Mar 2025InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNADeviceClass II1Ongoing
31 Jan 2025Paradigm REF: MMT-712 and MMT-715DeviceClass II12Ongoing
31 Jul 2024MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851DeviceClass I3Ongoing
15 Nov 2023Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3DeviceClass II1Ongoing
19 Feb 2016CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose informationDeviceClass II1Terminated
25 Sep 2015MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous…DeviceClass II2Terminated
22 Jul 2015Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.DeviceClass II1Terminated
19 Jun 2015MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.DeviceClass II1Terminated
10 Nov 2014CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory…DeviceClass III1Terminated
4 Nov 2014Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864,…DeviceClass II1Terminated
21 Jul 2014Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The…DeviceClass II1Terminated
16 Jun 2014Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007DDeviceClass II1Terminated
13 Mar 2014Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Medtronic MiniMed, Inc.: events for each product type
TypeEvents
Device23
Medtronic MiniMed, Inc.: events in each class
ClassEvents
Class II21
Class I1
Class III1
Share of the events of the firm in Class I
4%
Share of all events on the register in Class I
18%
Events with the status Ongoing
14

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Medtronic MiniMed, Inc., by the year that the recall started. The largest year is 2025, with 7 events.

Official channels

Cite this page

Recall Register. Medtronic MiniMed, Inc.: FDA recalls. https://recallregister.com/firm/medtronic-minimed-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Medtronic MiniMed, Inc. have?
Class II: 21 events. Class I: 1 event. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Medtronic MiniMed, Inc.?
FDA event 99374, which the firm started on 13 Jul 2026. The first product in the record is: MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
How many FDA recalls of Medtronic MiniMed, Inc. have the status Ongoing?
14 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.