Medtronic MiniMed Infusion Pump Recall Issued Over Risk of Hypo- or Hyperglycemic Reactions

Manufacturer has issued a medical device correction after identifying a design flaw that may cause the infusion pump to deliver too little or too much insulin.

The U.S. Food and Drug Administration (FDA) has announced three separate recalls impacting more than half a million Medtronic MiniMed insulin pumps, warning that a design flaw may cause the devices to deliver incorrect insulin doses when positioned above or below the infusion site due to changes in fluid pressure.

Medtronic MiniMed insulin pumps are designed to help individuals with diabetes regulate blood glucose levels. They provide a steady, continuous flow of insulin throughout the day, along with extra doses when needed.

However, if the pump delivers too much or too little insulin, serious or potentially life-threatening complications may occur. Too much insulin can cause hypoglycemia, leading to confusion, seizures or even death, while too little insulin can cause high blood sugar and, over time, diabetic ketoacidosis, another life-threatening condition.

Medtronic MiniMed Recall

The FDA recall impacts 13,811 MiniMed 700G insulin pumps, 95,704 MiniMed 770G pumps and 453,144 MiniMed 780G pumps, all of which are in circulation and have been distributed across the U.S. and internationally.

Customers began receiving correction notices from the manufacturer via email, SMS, certified mail and in-app push notifications on February 13, informing them of the updated user guides. 

The notices advise users to keep the pump in a stable position and not to wear or place the device more than 14 inches (35.5 cm) above the infusion site, as doing so may result in over-delivery of insulin and increase the risk of hypoglycemia.

The guidance further recommends limiting the amount of time the pump is positioned above the infusion site when elevation cannot be avoided. Users are also instructed to closely monitor pump alerts and watch for any signs of blood sugar fluctuations.

The FDA has classified the recall as Class II, indicating that the affected devices may pose a risk of temporary or medically reversible health effects.

Customers are encouraged to complete and return acknowledgment forms by visiting https://info.medtronicdiabetes.com/pump-placement. For additional questions, Medtronic can be contacted at 1-855-587-4950.

Medtronic MiniMed Lawsuits

The Medtronic MiniMed insulin pump has been the subject of multiple recalls and lawsuits in recent years, driven by ongoing safety concerns involving insulin dosing errors, device malfunctions and cybersecurity vulnerabilities. As a result, many patients and families have filed MiniMed lawsuits after experiencing severe injuries or the loss of loved ones.

In August 2023, a MiniMed wrongful death lawsuit was filed following a fatal insulin overdose linked to a MiniMed pump. According to the complaint, Michael E. Domanowski properly prepared his insulin pump before going to sleep on August 9, 2020. After he failed to report to work for several days, he was later found deceased in his home.

Investigators determined that the device had delivered an excessive amount of insulin, potentially equivalent to an entire week’s dosage in a single event. The overdose caused severe hypoglycemia, ultimately resulting in his death. An autopsy later confirmed critically low blood sugar levels.

The lawsuit further alleges that the specific MiniMed pump involved was later recalled due to known risks of malfunction and insulin over-delivery. It also claims Medtronic representatives contacted the family shortly after his death to inform them of the recall, which plaintiffs argue reflects prior awareness of the defect.

Additional concerns have been raised in other regulatory actions. In September 2022, the FDA warned that certain MiniMed pumps contained cybersecurity vulnerabilities that could allow unauthorized access to the device’s wireless communication system when in close proximity. This risk was heightened when the pump was connected to other devices, such as continuous glucose monitors, blood glucose meters or CareLink USB systems.

Dosing issues were also identified in a February 2020 recall of MiniMed insulin pumps, which preceded a number of lawsuits. In one case filed in March 2020, a woman alleged that her Medtronic infusion pump malfunctioned, resulting in an insulin overdose. She reportedly fell into a diabetic coma, experienced seizures and suffered additional complications as a result.

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