FDA Cardiobeat

FDA CardioBeat Email Updates provide information about FDA cardiovascular product approval, safety warnings, medical product labeling changes, notices of upcoming meetings, and notices about proposed regulatory guidances. The FDA recently approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. "Firmware" is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator). The FDA recommends that all eligible patients receive the firmware update at their next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. 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. This firmware update includes mitigations to addresses two separate issues: 1) a device-based Battery Performance Alert to detect rapid battery depletion in devices subject to the Battery Advisory from October 2016; and 2) updates to address cybersecurity vulnerabilities across Abbott's radio frequency (RF) enabled ICDs and CRT-Ds. Steve Morin Office of Health and Constituent Affairs Food and Drug Administration