Medical device manufacturer Medtronic has issued an urgent recall of a recent software update for its MiniMed 780G insulin pump system after receiving reports of dosage calculation errors that resulted in incorrect insulin delivery. The FDA has classified the recall as Class I, its most serious category, indicating the defect could cause serious injury or death.
The software update, version 4.2.1, introduced a rounding error in the bolus calculator function that could lead to insulin over-delivery of up to 15 percent in certain scenarios. Medtronic has confirmed 47 adverse event reports, including 12 cases requiring emergency medical treatment for hypoglycemia, though no fatalities have occurred.
Affected users have been instructed to revert to the previous software version immediately and contact Medtronic's 24-hour support line for assistance. The company is developing a corrected update expected to be available within two weeks.
