Medtronic MiniMed recalls
19 official recalls and safety alerts involving Medtronic MiniMed since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic MiniMed or the relevant agency.
- 2026-10-14
USMedtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The…
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The…
FDA · DeviceMedtronic MiniMed, Inc.U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI,…Official notice →- 2026-08-26
- US
Medtronic MiniMed, Inc. recalls 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 in insulin over- or under-delivery, potentially causing…
FDA · DeviceMedtronic MiniMed, Inc.International distribution to the countries of Germany, Denmark, Austria,…Official notice → - 2026-07-29
- US
Medtronic MiniMed, Inc. recalls 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 associated alerts will not be triggered during the nighttime. This…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution in the states and territories of PR,…Official notice → - 2026-07-15
- US
Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53…
FDA · DeviceMedtronic MiniMed, Inc.International distribution to the countries of Spain, Great Britain,…Official notice → - 2026-04-08
- US
Medtronic MiniMed, Inc. recalls 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 insulin when the pump is elevated or lowered relative to the…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution including in the states of OR, CA, AZ,…Official notice → - 2026-04-01
- US
Medtronic MiniMed, Inc. recalls 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, and 6.62), which could result in a risk of hypoglycemia or…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2026-02-11
- US
Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for…
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 suspension of insulin delivery.
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. National distribution including in the states of AL, AR, AZ,…Official notice → - 2025-12-24
- US
Medtronic MiniMed, Inc. recalls 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 allow notifications to override phone settings when on…
FDA · DeviceMedtronic MiniMed, Inc.US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI,…Official notice → - 2025-12-03
- US
Medtronic MiniMed, Inc. recalls 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 incorrect data displayed on the 24-hour sensor glucose overview…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA,…Official notice → - 2025-10-08
- US
Medtronic MiniMed, Inc. recalls 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.
FDA · DeviceMedtronic MiniMed, Inc.US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United…Official notice → - 2025-09-10
- US
Medtronic MiniMed, Inc. recalls 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 reminder and a recommendation to correct a high glucose…
FDA · DeviceMedtronic MiniMed, Inc.International distribution to the countries of Argentina, Australia, Austria,…Official notice → - 2025-04-30
- US
Medtronic MiniMed, Inc. recalls 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 holder; or the cartridge holder may be difficult to remove…
FDA · DeviceMedtronic MiniMed, Inc.US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH,…Official notice → - 2025-03-12
- US
Medtronic MiniMed, Inc. recalls 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 changes in air pressure, which can be found during airplane…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2024-10-09
- US
Medtronic MiniMed, Inc. recalls MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754,…
Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life…
FDA · DeviceMedtronic MiniMed, Inc.US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA,…Official notice → - 2024-02-14
- US
Medtronic MiniMed, Inc. recalls Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1,…
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 function (sensor glucose value) or loss of sensor…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution including in the states of PR, AK, AL,…Official notice → - 2023-01-11
- US
Medtronic MiniMed recalls 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 upload data. When logged out, linked care partners will not…
FDA · DeviceMedtronic MiniMedOUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland,…Official notice → - 2022-11-16
- US
Medtronic MiniMed recalls 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 unauthorized access to the pump system. This unauthorized…
FDA · DeviceMedtronic MiniMedUS: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS,…Official notice → - 2022-07-20
- US
Medtronic MiniMed recalls 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/functionality of the insulin infusion pumps.
FDA · DeviceMedtronic MiniMedU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - 2022-04-06
- US
Medtronic MiniMed recalls MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781,…
New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do…
FDA · DeviceMedtronic MiniMedUS: OH, UT, IL, NY, FL, LA, NE, NV, CA, VA, TX, DE, KS, MS, MI, AL, OK, AZ,…Official notice →