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. You can read get more details on the recalls on the FDA website for the 780G here and other systems here.

According to the FDA, in certain situations there may be slight variability in the amount of insulin delivered 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 hypoglycemia (low blood sugar) or hyperglycemia (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. The company says no complaints or reports about this issue were received and that this is a notification only and no product replacement is required.

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.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.