Medtronic Inc.

Medtronic MiniMed insulin pumps (including the 780G model and older Paradigm and 600 series) may deliver too much or too little insulin when the pump is held higher or lower than the infusion site on your body. This happens because gravity affects how insulin flows through the tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is positioned higher or lower than your infusion site. This happens because gravity changes the pressure inside the pump. Too much insulin can cause dangerous low blood sugar; too little can cause dangerous high blood sugar and other complications.

Medtronic MiniMed insulin pumps can deliver too much or too little insulin when the pump is positioned higher or lower than the infusion site on your body. This happens because gravity affects the pressure inside the pump tubing. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar.

Medtronic has recalled certain MiniMed 780G insulin pumps due to software defects that can cause the pump to deliver too much insulin, too little insulin, or stop delivering insulin entirely. These defects appeared after software updates (versions 6.60, 6.61, and 6.62) and may result in dangerously high or low blood sugar levels. The recall affects over 26,000 pumps with specific serial numbers.

Medtronic found a manufacturing error in 2 units of the Octopus Nuvo Tissue Stabilizer where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite of the correct design. This could affect how the device functions during use.

Some Medtronic MiniMed 780G insulin pumps with software version 6.60 may experience a software timing issue that triggers an error code and stops insulin delivery. This affects specific catalog numbers (MMT-1884, MMT-1886) with certain serial numbers.

Medtronic has recalled certain Abre Venous Self-Expanding Stents due to a manufacturing issue with the stent material (Nitinol) that can cause the stent to be smaller than intended when deployed. This reduced size may result in the stent moving out of position after placement.

A software problem in the Medtronic Restore Clinician Programmer App (versions before v.1.0.4489) can cause a Device Reset message that cannot be cleared. In rare cases, this prevents the pain management device from resuming therapy, causing patients to experience pain symptoms again. The implanted devices themselves are not affected—only the programmer application used by clinicians.

Medtronic MiniMed InPen App users on Android (versions 7.5.0, 7.5.1, and 8.0.0) may lose insulin reminders if they uninstall and reinstall the app. The notification settings screen doesn't appear during setup, preventing notifications from overriding your phone's mute or Do Not Disturb mode. This could delay insulin therapy.

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

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.

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.

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.