IMPORTANT MEDICAL DEVICE SAFETY INFORMATION
At Medtronic, we are committed to continuing to improve our products and services to enable people to manage diabetes. We recently sent a letter to notify U.S. Paradigm users and their healthcare professionals of two potential issues relating to Paradigm insulin pumps.
We are informing our customers of the potential for a loose drive support cap. In rare cases, the cap may stick out from the side of the insulin pump as a result of impact(s) with a hard surface. The letter also reminds our customers of the existing User Guide instructions that exposure to water can damage the insulin pump's internal electronics.