More Than 900,000 Diabetes Devices Have Been Recalled Nationwide

According to 2021 data from the American Diabetes Association, 2 million Americans have type 1 diabetes—304,000 of which are either children or adolescents. And many of those individuals rely on insulin pumps to regulate their bodies and avoid complications, which is why a new FDA recall announcement should be heeded.

On March 3, the U.S. Food and Drug Administration (FDA) updated a January recall for 912,119 total Medtronic MiniMed insulin pump products. It is now categorized as a Class II event, meaning the affected product “may cause temporary or medically reversible adverse health effects.”

The FDA states, “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.” The report notes that this occurs during an airplane’s takeoff and landing.

The report goes on to detail the potentially serious consequences of the possible malfunction. It states: “An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death.” It continues, “An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.”

The Cleveland Clinic describes diabetic ketoacidosis as a “life-threatening complication” when the body doesn’t have enough insulin and the liver begins to break down body fat as an energy source instead. This process, in turn, causes a buildup of acids called ketones. As a result, a “high number of ketones causes your blood to become acidic (your blood pH is too low) and you experience dehydration.” Diabetic ketoacidosis is a medical emergency and requires immediate medical attention.

The FDA’s report lists all 50 states in the distribution portion, as well as Washington, D.C., Puerto Rico, and the U.S. Virgin Islands. An expansive list of other countries is included as well.

The report highlights the following insulin pump products with these details:

• Paradigm insulin pump
  • Reference information: MMT-712 and MMT-715
  • 20,760 total units
• Paradigm insulin pump
  • Reference information: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
  • 46,437 total units
• Paradigm insulin pump
  • Reference information: MMT-754
  • 41,404 total units
• MiniMed 620G insulin pump
  • Reference information: MMT-1750
  • 228 total units
• MiniMed 630G insulin pump
  • Reference information: MMT-1714, MMT-1715, MMT-1754, MMT-1755
  • 70,587 total units
• MiniMed 640G insulin pump
  • Reference information: MMT-1711, MMT-1712, MMT-1751, MMT-1752
  • 168,240 total units
• MiniMed 670G insulin pump
  • Reference information: MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782
  • 100,074 total units
• MiniMed 700G insulin pump
  • MMT-1801, MMT-1805, MMT-1850, MMT-1851
  • 4,959 total units
• MiniMed 720G insulin pump
  • Reference information: MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867
  • 8,677 total units
• MiniMed 740G insulin pump
  • Reference information: MMT-1811, MMT-1812, MMT-1861, MMT-1862
  • 15,439 total units
• MiniMed 770G insulin pump
  • Reference information: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892
  • 106,289 total units
• MiniMed 780G insulin pump
  • Reference information: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
  • 329,025 total units

The recalling firm is listed as Medtronic MiniMed, Inc. in Northridge, CA. In recent months, the company recalled 785,000 MiniMed products due to battery issues.

A February 2025 alert found on the Canadian version of the Medtronic website, which not does not appear to contain the latest details included in the FDA’s report, further explains the air pressure issue was discovered during “quality testing performed by Medtronic.” The company says, “Between July 2003 and May 2024, Medtronic received 138 complaints potentially related to this issue, 19 of which reported serious injuries, but none were confirmed to be related to this issue.”

It is not immediately clear why recall details were not included for the MiniMed 530G model, despite its inclusion in the overall model and series list provided by the FDA with the potential to malfunction.

Medtronic’s notice recommends pump users monitor glucose levels, talk with a healthcare professional to prepare for similar emergency situations, and respond to pump alerts and any possible symptoms. It is not clear from the company’s website or the FDA report if users are able to get a refund.

Amazon also provided a link to the recall information, though it does not appear the insulin pumps are available to purchase directly on the retailer’s website at this time.

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