Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

Core Points - Medtronic has issued a voluntary field action regarding its MiniMed™ 600 and 700 series insulin pumps due to reports of shortened battery life and potential health risks associated with battery alerts and insulin delivery interruptions [1][2][3] - The FDA has classified this action as a class I recall, indicating a significant risk to patient safety [1] - Medtronic emphasizes the importance of patient safety and has established a 24/7 support system for users experiencing battery issues [3] Summary by Sections Product Issue - Customers are advised to monitor built-in alerts for battery status and contact Medtronic for pump replacement if they notice changes in battery life [1] - A comprehensive analysis revealed that physical impacts to the pump can lead to reduced battery life and premature battery alerts [1][2] - Medtronic has received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis potentially related to this issue from January 2023 to September 2024 [1] Customer Guidance - Users should be prepared to replace the battery immediately upon receiving a "Low Battery Pump" alarm, as the pump may stop insulin delivery sooner than expected [2] - It is recommended that users carry extra batteries and have backup therapy available [2] Company Commitment - Medtronic prioritizes patient safety and continuity of therapy, actively notifying impacted users since July 2024 [3] - The company is committed to replacing pumps when necessary and providing ongoing support to users [3] Company Overview - Medtronic is a global leader in healthcare technology, aiming to transform diabetes care and improve patient outcomes [4][5] - The company employs over 95,000 people across more than 150 countries, addressing various health conditions with innovative technologies [5][6]