Medtronic has issued a recall of the company’s MiniMed model insulin pump due to a potential cybersecurity risk.
According to a notice issued by the U.S. Food and Drug Administration (FDA) in early November, Medtronic’s MiniMed insulin pump is susceptible to hacking. By recording and replaying the wireless communication between the pump and the pump’s optional remote control device, an unauthorized person could instruct the pump to either over-deliver insulin to a patient or stop delivery of insulin altogether.
The FDA says that it is unaware of any reports of patient harm related to the potential cybersecurity risks. However, it has classified the recall as a Class I recall, which is reserved for recalled devices that could cause either serious injury or death.
The MiniMed insulin pump has been distributed in the U.S. for more than 10 years. The company estimates that more than 1100 of the recalled pumps were distributed during that period.