The U.S. FDA has issued a Class I recall on Medtronic’s wireless insulin pump remote controllers. The FDA notified patients of the recall—the most serious type—because of problems with the devices that could cause serious injury or death.
The recalled remote controllers are used with either the Medtronic’s MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps, due to potential cybersecurity risks, the FDA says.
In a security bulletin also issued Tuesday about the recall, Medtronic says an external security researcher identified a potential vulnerability related to the MiniMed Paradigm family of insulin pumps and corresponding remote controller.
“When used together, the Paradigm insulin pump and remote controller—similar to a key fob—allow a diabetes patient to easily self-deliver a bolus—a dose of insulin given by a pump—without physically accessing their insulin pump,” Medtronic says.
Read the full story at govinfosecurity.