Medtronic plc, an Irish company specializing in healthcare technology, has issued a recall for its MiniMed 600 and 700 series insulin pumps due to potential risks associated with reduced battery life. The U.S. Food and Drug Administration (FDA) designated this action as a Class I recall following reports of 170 hyperglycemia incidents exceeding 400mg/dL and 11 cases of diabetic ketoacidosis in the U.S. from January 2023 to September 2024.
The company initiated a global field notification on July 31, 2024, advising users of MiniMed 600 and 700 models to closely monitor their device’s built-in battery alerts and alarms. Users noticing changes in battery performance are advised to contact Medtronic for further measures.
Medtronic's investigation was triggered by customer reports of reduced battery life. Their detailed analysis revealed that if these devices have been subjected to physical impacts such as being dropped or bumped, even once, they might experience shortened battery life due to potential damage to internal electrical components.
This electrical issue can result in battery alerts when less battery life remains than specified in the User Guide. This discrepancy may cause the insulin pump to stop delivery much earlier than anticipated, posing risks such as hyperglycemia or diabetic ketoacidosis (DKA), which could necessitate medical assistance.
The company highlighted that a single incident of dropping the pump could cause immediate or cumulative damage leading to reduced battery life, persisting even after a battery replacement. Although the pumps will continue to issue battery notifications, these warnings might occur with less remaining battery life than usual, prompting the need for a quicker replacement to prevent interruptions in insulin delivery. Users are advised to replace the battery promptly upon receiving the "Low Battery Pump" alert.
Medtronic recommends that users always have a spare set of new AA lithium or alkaline batteries, or fully charged NiMH batteries, on hand should an earlier-than-expected replacement be necessary. Those experiencing any issues are encouraged to reach out to their local Medtronic team to determine if a replacement pump is required.
