Medtronic MiniMed, Inc. Recalls

All product recalls associated with Medtronic MiniMed, Inc..

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Recall Summary

Total Recalls

300

Past Year

25

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 300 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.

Aurora EV-ICD (Medtronic) – High-Voltage Therapy Delay (2025)

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Moderate

FDAOct 29, 2025Nationwide• Medtronic, 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.

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Moderate

FDASep 16, 2025Nationwide• Medtronic Sofamor Danek USA Inc

IPC Powerease System (Medtronic) – Driver Wobble Issue (2025)

Due to out of the box wobble of the driver.

Moderate

FDAJul 17, 2025AZ, CA, CO +22 more• Medtronic Xomed, Inc.

Medtronic CareLink Patient Connector (Medtronic) – Test Abort Issue (2025)

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Moderate

FDAJun 18, 2025Nationwide• Medtronic, Inc.

Medtronic CareLink SmartSync (Medtronic) – Test Abort Issue (2025)

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Moderate

FDAJun 18, 2025Nationwide• Medtronic, Inc.

Medtronic SmartLink Software (Medtronic) – Display Error Update (2025)

A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

Moderate

FDAJun 17, 2025Nationwide• Medtronic, 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.

O-arm O2 Imaging System (Medtronic) – Gantry Support Damage (2025)

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

Moderate

FDAMay 27, 2025Nationwide• Medtronic Navigation, Inc.-Boxborough

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.

Azure S DR MRI SureScan (Medtronic) – Battery Failure Risk (2025)

Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.

Moderate

FDAApr 29, 2025Nationwide• Medtronic, Inc.

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

Moderate

FDAMar 10, 2025Nationwide• Medtronic Xomed, 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 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 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.

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.

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.

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.

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.

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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)

Aurora EV-ICD (Medtronic) – High-Voltage Therapy Delay (2025)

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

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

IPC Powerease System (Medtronic) – Driver Wobble Issue (2025)

Medtronic CareLink Patient Connector (Medtronic) – Test Abort Issue (2025)

Medtronic CareLink SmartSync (Medtronic) – Test Abort Issue (2025)

Medtronic SmartLink Software (Medtronic) – Display Error Update (2025)

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

O-arm O2 Imaging System (Medtronic) – Gantry Support Damage (2025)

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

Azure S DR MRI SureScan (Medtronic) – Battery Failure Risk (2025)

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

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

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

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

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

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

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

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