Medtronic MiniMed, Inc. Recalls

All product recalls associated with Medtronic MiniMed, Inc..

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Recall Summary

Total Recalls

20

Past Year

16

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 20 recalls

InPen App, Model/CFN Number: MMT-8061 (Android Users) (Medtronic MiniMed, Inc.) – when app is uninstalled and reinstall... (2025)

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 mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

Moderate

FDANov 13, 2025AL, AK, AZ +47 more• Medtronic MiniMed, Inc.

CareLink Clinic (Medtronic) – Graph Data Inaccuracy (2025)

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 graph may lead to hypoglycemia or hyperglycemia.

Moderate

FDAOct 21, 2025Nationwide• Medtronic MiniMed, Inc.

InPen App (Medtronic) – Insulin Dosing Error (2025)

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 value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.

Moderate

FDAJun 16, 2025GA• Medtronic MiniMed, Inc.

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

Moderate

FDAMay 7, 2025Nationwide• Medtronic MiniMed, Inc.

InPen Smart Insulin Pen (Medtronic) – Assembly Error (2025)

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 from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

Moderate

FDAMar 4, 2025AL, AZ, AR +38 more• Medtronic MiniMed, Inc.

MiniMed 620G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 670G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 700G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 720G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 770G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 780G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed Insulin Pump (Medtronic) – insulin delivery (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 630G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

MiniMed 640G Insulin Pump (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

Paradigm Insulin Pump MMT-712/715 (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

Paradigm Insulin Pump MMT-522/551/722 (Medtronic) – delivery risk (2025)

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 take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Very High

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

Medtronic MiniMed, Inc.: MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580,...

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 overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

Moderate

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Medtronic MiniMed, Inc.: MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, 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 battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

Moderate

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Medtronic MiniMed, Inc.: 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 battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

Moderate

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Medtronic MiniMed, Inc.: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MM...

Laceration Risk

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 function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.

Moderate

FDANov 15, 2023Nationwide• Medtronic MiniMed, Inc.

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Medtronic MiniMed, Inc. Recalls

Recall Summary

InPen App, Model/CFN Number: MMT-8061 (Android Users) (Medtronic MiniMed, Inc.) – when app is uninstalled and reinstall... (2025)

CareLink Clinic (Medtronic) – Graph Data Inaccuracy (2025)

InPen App (Medtronic) – Insulin Dosing Error (2025)

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

InPen Smart Insulin Pen (Medtronic) – Assembly Error (2025)

MiniMed 620G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed 670G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed 700G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed 720G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed 770G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed 780G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed Insulin Pump (Medtronic) – insulin delivery (2025)

MiniMed 630G Insulin Pump (Medtronic) – delivery risk (2025)

MiniMed 640G Insulin Pump (Medtronic) – delivery risk (2025)

Paradigm Insulin Pump MMT-712/715 (Medtronic) – delivery risk (2025)

Paradigm Insulin Pump MMT-522/551/722 (Medtronic) – delivery risk (2025)

Medtronic MiniMed, Inc.: MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580,...

Medtronic MiniMed, Inc.: MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1...

Medtronic MiniMed, Inc.: MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1...

Medtronic MiniMed, Inc.: Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MM...