U.S. FDA Safety Communication-Cybersecurity-Medtronic Implantable Cardiac Device Programmers

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is issuing this safety communication to alert you that Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection between the Carelink 2090 and Carelink Encore 29901 Programmers used to download software from the Medtronic SDN. This update is a correction (voluntary recall) by the manufacturer to address the safety risk caused by the cybersecurity vulnerability.

For the purposes of this safety communication, cybersecurity focuses on protecting patients’ medical devices and their associated computers, networks, programs, and data from unintended or unauthorized threats.

For the full FDA Safety Communication see