The Food and Drug Administration (FDA) has issued a Class II recall for several MiniMed insulin pump models, affecting the MiniMed 780G, 640G, 770G, and 700G series.
According to the FDA, the affected pumps were delivering incorrect amounts of insulin due to gravity-related pressure changes, which could result in too much or too little insulin being administered. These malfunctions carry serious health risks, including life-threatening hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar).
MiniMed has already begun notifying affected users of the issue and is instructing them that they should not wear the pump more than 14 in (35.5 cm) above an infusion site.
Despite the recall, MiniMed's pipeline of upcoming innovations remains on track. The company is expected to launch a new tubed pump, the MiniMed Flex later this year, and is also developing a fully closed-loop algorithm called Vivera. MiniMed also recently began a wear study for a tubeless pump currently in-development called MiniMed Fit.
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Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.