WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued a Class I recall, the most serious type, on Medtronic’s MiniMed™ 600 and 700 series insulin pumps following reports of potential battery malfunctions. This action, initiated by Medtronic on July 31, 2024, comes after the company discovered that physical impacts, such as drops or bumps, can lead to internal damage that shortens battery life and causes alerts to trigger later than intended.
The recall is primarily concerned with the potential health risks posed by the pumps’ failure to provide timely battery warnings. This malfunction could halt insulin delivery prematurely, leading to serious conditions such as hyperglycemia or diabetic ketoacidosis (DKA). To date, Medtronic has recorded 170 incidents of hyperglycemia and 11 of DKA in the United States from January 2023 to September 2024, possibly linked to this issue.
In response, Medtronic has updated its guidance, advising users to be vigilant about battery status alerts and to carry extra batteries. “Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes,” stated Robert Vigersky, MD, Chief Medical Officer of Medtronic Diabetes. He further assured, “Our team is here 24 hours a day, 7 days a week to help if you experience battery depletion or any other issue with your pump. Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed.”
Medtronic urges users who detect a significant drop in battery life to contact their local support team for a potential replacement. The company has made both the initial and updated notifications available on the Medtronic Diabetes website.
The FDA’s classification of this recall highlights the critical nature of the issue, reinforcing the necessity for affected users to remain alert and proactive in managing their devices.
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