The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.
The potential risks are related to the wireless communication between Medtronic's MiniMed insulin pumps and other devices such as blood glucose meters, continuous glucose monitoring systems, the remote controller and CareLink USB device used with these pumps. The FDA is concerned that, due to cybersecurity vulnerabilities identified in the device, someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump’s settings.
This could allow a person to over deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or to stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis (a buildup of acids in the blood).
The recalled pumps are Medtronic’s MiniMed 508 insulin pump and MiniMed Paradigm series insulin pumps. Medtronic is providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities. In the U.S., Medtronic has identified 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue. In addition, Medtronic is working with distributor partners to identify additional patients potentially using these pumps.