FDA Recalls Medtronic Insulin Pump Controller, Cites Cybersecurity Risks

Health IT Security

Jill McKeon

The US Food and Drug Administration (FDA) issued a Class I recall on all Medtronic MiniMed remote controllers used with the Medtronic MiniMed 508 insulin pump or the MinMed Paradigm family of insulin pumps, citing significant cybersecurity concerns.

Medtronic urged users to immediately discontinue use, disconnect the remote controller, disable the remote feature, and return the controller to Medtronic. The remote controlled device allows users to communicate with the pump wirelessly to deliver a specific dose of insulin.

“An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump,” the FDA explained.

“Using specialized equipment, an unauthorized person could...

Get the Morning Update

Thanks for subscribing!