FDA warns about potential cybersecurity concerns with certain Medtronic insulin pumps

SILVER SPRING, Md. (WPVI) -- 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.

It recommends patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.

To date, the FDA says there have been no reports of patients being harmed by hacked MiniMed pumps. .

The potential risks are related to the wireless communication between the 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 vulnerabilities in the devices would allow someone other than a patient, caregiver or health care provider to wirelessly connect to the pump and change its settings.

That could lead to low blood sugar (hypoglycemia) or stopping 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.