The U.S. Food and Drug Administration on Thursday announced a Class 1 recall for Medtronic MiniMed 600- and 700-series insulin pumps because of an increased risk of shorter battery life that could unexpectedly stop therapy.
Medtronic MiniMed insulin pumps recalled over shorter-than-expected battery life
Patients urged to carry extra batteries as Medtronic recall affects 24,595 insulin pumps that may stop delivering insulin sooner than expected.
The Minnesota Star Tribune
October 18, 2024 at 8:47PM
Medtronic, which has operational headquarters in Fridley, has recalled 24,595 battery-operated pumps after it discovered devices that have been dropped, bumped or damaged may develop electrical issues that stop insulin delivery sooner than expected after an alarm sounds, the agency said.
Medtronic has received 11 reports of the issue potentially leading to diabetic ketoacidosis, a life-threatening complication of diabetes that occurs when the body doesn’t have enough insulin. Class I recalls are reserved for situations when there’s a reasonable chance that using a device would lead to serious health problems or death. No fatalities have been reported.
The recall does not require users to stop using their pumps. Rather, the company has advised users to carry an extra set of batteries at all times, and if a significant decrease in battery life is noticed, they should contact their local Medtronic team to see if a replacement pump is needed. Customers in the U.S. 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 have displayed the alert about 2½ hours before shutting down, and some users have reported the window is even shorter, the agency said.
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