Medtronic MiniMed has issued a Class II recall of its CareLink Clinic diabetes therapy management software due to incorrect data display.
The recall, initiated Oct. 21, affects software version 4.2B, used for continuous glucose monitor retrospective data analysis, according to a Nov. 25 notice from the FDA. A software error caused inaccurate information to appear on the 24-hour sensor glucose overview graph, potentially leading to hypoglycemia or hyperglycemia.
The issue affected 12,126 units distributed across the U.S. and more than 60 countries. Medtronic released software version 4.2C to correct the error.
Medtronic advised clinicians who made treatment recommendations using the affected data to review patients’ individual CareLink reports, which were not impacted. Customers were also sent device correction notices.
