Medtronic has been notifying users of its MiniMed insulin pumps to be aware of potentially shortened battery lives and to heed the devices’ low-power warnings and alerts. Now, the FDA has elevated the efforts into a Class I recall, the agency’s most serious category, following reports of dangerously high blood sugar levels.
The medtech giant first began reaching out to people with diabetes and healthcare providers about the issue in late July. The company said its analysis found that dropping or bumping the MiniMed 600 and 700 series pumps could damage the internal electric hardware, and then cause the battery to drain more quickly—ultimately increasing the risk of the pump stopping or slowing the delivery of insulin sooner than expected.
Medtronic said that, between January 2023 to September of this year, it has received 170 reports of hyperglycemia, or blood sugar readings over 400 mg/dL, as well as 11 cases of diabetic ketoacidosis.
The company said that physical impacts to the pump could either immediately reduce its battery life or affect it over time and that the issue could continue even after replacing it with a new battery.
Medtronic also said: “The pump will still generate battery alerts and alarms, but these alerts and alarms may not be delivered with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery,” and urged users to always carry a spare set of batteries and to swap them in as soon as the alarm goes off.
The MiniMed pumps are designed to first alert the user to a low battery with about 10 hours of time remaining. According to the FDA, some pumps only lasted about two-and-a-half hours or less. The agency estimated that about 785,000 devices may be in circulation, across multiple models.
“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,” Robert Vigersky, Medtronic Diabetes’ chief medical officer, said in a statement, adding that pumps would be replaced as needed. “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.”