Medtronic Insulin Pump Air Pressure Issues Could Lead to Dangerously Low Blood Sugar Levels

Manufacturer issued a medical device correction after identifying a design flaw that may cause the insulin pumps to malfunction during airplane flights.

Federal health officials have announced a recall impacting 41,404 Medtronic MiniMed insulin pumps, due to a risk that the devices may deliver incorrect insulin doses if they are exposed to air pressure fluctuations, such as those experienced during airplane takeoff and landing.

Medtronic MiniMed insulin pumps are medical devices used by people with diabetes to help manage blood sugar levels. They deliver a continuous supply of insulin throughout the day and additional doses as needed.

However, the U.S. Food and Drug Administration (FDA) issued the Medtronic MiniMed insulin pump recall on March 3, warning that the device may deliver incorrect insulin doses in response to air pressure fluctuations. These changes can occur during airplane flights, high-altitude hikes, rapid elevator rides in skyscrapers, or travel through mountainous regions.

Unexpected over-delivery of insulin during these moments could result in severe hypoglycemia, leading to altered mental states, seizures, coma or death. In addition, unexpected under-delivery could cause severe hyperglycemia, dehydration, diabetic ketoacidosis or death.

Medtronic first issued an urgent medical device correction notice about the potential issues on January 31, advising customers to monitor their glucose levels, discuss with their doctors any strategies for managing changes in air pressure, and respond promptly to alerts and symptoms. The FDA has classified the action as a class 2 medical device recall.

The recalled Medtronic MiniMed insulin pumps were distributed globally, and across all U.S. states and territories, including Paradigm, MiniMed 530G, 6XX and 7XX series pumps, covering all lot numbers and Unique Device Identifier (UDI) numbers.

Customers with questions can contact Medtronic Technical Support at 1-800-646-4633, ext. 1 for further assistance.

Medtronic MiniMed Lawsuits

The Medtronic MiniMed has been at the center of multiple recalls and lawsuits in recent years, due to serious defects that could cause insulin overdoses, cybersecurity vulnerabilities and dangerous dosing errors. This led to a wave of MiniMed lawsuits filed by patients who suffered severe injuries or lost loved ones, and raised significant concerns about the safety of Medtronic’s insulin pump technology.

In August 2023, a MiniMed wrongful death lawsuit was filed against Medtronic after a man fatally overdosed on insulin when his MiniMed pump malfunctioned. 

According to the lawsuit, Michael E. Domanowski properly loaded his insulin pump before going to bed on August 9, 2020, but was later found dead on his floor after failing to show up for work for several days. Investigators determined that the pump had delivered up to a week’s worth of insulin in a single dose, causing severe hypoglycemia that led to his painful and prolonged death. A post-mortem examination confirmed dangerously low blood sugar levels throughout his body.

The MiniMed pump used by Domanowski was later recalled due to the risk of malfunction and overdose, the lawsuit noted. Medtronic employees contacted the family within a few days of his death to alert Domanowski about the recall. However, the lawsuit says it was an attempt “to cover their own misconduct.”

In September 2022, the FDA issued a warning about potentially deadly cybersecurity vulnerabilities in certain MiniMed insulin pumps. The FDA warned that the pump systems wireless communication software could be accessed by a nearby unauthorized user while the pump is paired with other system components like continuous glucose monitoring systems, blood glucose meters and CareLink USB devices.

Dosing problems were also mentioned in a February 2020 MiniMed insulin pump recall, which preceded numerous lawsuits, including one from a South Carolina woman filed in March of that year, alleging that her Medtronic infusion pump malfunctioned. As a result, she was overdosed with insulin, fell into a diabetic coma, suffered seizures, and sustained other injuries.