Medtronic recalls data management software, urging healthcare providers to run update
Medtronic is recalling its CareLink Clinic software due to an error that was causing incorrect glucose data to be displayed to healthcare providers. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited immediately.
The error only impacted CareLink Clinic’s 24-Hour Sensor Glucose Overview Graph feature, the company emphasized in its message to customers. Data seen on other charts should have still been correct.
The software version behind this specific error was available in the United States from Sept. 4 to Oct. 3, 2025. It was available outside of the United States from Sept. 11 to Oct. 4, 2025.
The software was available in the United States for clinical use, meanwhile, from Aug. 21 to Oct. 3, 2025. It was available outside of the United States for clinical use from Aug. 21 to Oct. 4, 2025.
Updating to the most recent software, version 4.2C, should correct this issue for any CareLink Clinic users.
The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall, which means using the products could cause “temporary or medically reversible adverse health consequences.” The risk of a serious adverse events, however, is low.
Medtronic estimated that more than 12,000 CareLink Clinic users may need to update their software to address this error.
Medtronic’s diabetes spin-off is on the way
Back in June, Medtronic announced that its diabetes spin-off will be officially known as Medtronic MiniMed. MiniMed was the original name of the medtech giant’s diabetes business before it was acquired by Medtronic in 2001. At the time, the company said the spin-off is expected to launch within the next 18 months.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.