FDA Sees Cybersecurity Risk in Some Medtronic Pumps

FDA says 11 Medtronic MiniMed and MiniMed Paradigm insulin pumps have potential cybersecurity risks and diabetes patients using the specific models should switch their insulin pump to models that are better equipped to protect against the potential risks. An FDA safety communication lists the 11 affected models and offers recommendations for people with diabetes and their caregivers.

The notice says the agency has become aware that an unauthorized person could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities and change the pump’s settings to either over-deliver insulin or stop insulin delivery.

Since Medtronic is unable to update the affected pumps to address the potential cybersecurity risks, FDA says, patients should replace the pumps with models better able to protect them from the risks.

FDA says it is not aware of any reports of patient harm related to the potential cybersecurity risks.