The U.S. Food and Drug Administration on Thursday announced a Class 1 recall action for Medtronic MiniMed 600- and 700-series insulin pumps because of an increased risk for shorter battery life that could unexpectedly stop insulin therapy.
Medtronic, which has operational headquarters in Fridley, recalled 24,595 battery-operated insulin pumps after it discovered devices that have been dropped, bumped or damaged may have electrical issues that stop insulin delivery sooner than expected after an alarm sounds, the agency said.
Medtronic has received 11 reports of the issue leading to diabetic ketoacidosis, a potentially life-threatening complication of diabetes that occurs when the body doesn’t have an adequate supply of insulin. Class I recalls are reserved for situations when there’s a reasonable chance that using a device will lead to serious health problems or death, though no fatalities have been reported.
The recall does not require users to stop using the insulin pumps. Rather, the company has advised users to carry an extra set of batteries with them at all times and to contact their local Medtronic team to see if a replacement pump is needed if they notice a significant decrease in battery life. In the United States, customers can call 1-800-378-2292 for support.
Medtronic expects MiniMed pumps to typically have up to a 10-hour buffer between a low-battery alert and a device shutdown, the FDA said. Some devices displayed the low-battery alert about 2.5 hours before device shutdown, with some users saying the window is even shorter, the agency said.
