FDA Approves Firmware Addressing Cybersecurity Vulnerabilities in Abbott Implantable Pacemakers

The U.S. Food and Drug Administration (FDA) recently approved a firmware update for certain Abbott (previously St. Jude Medical) pacemakers to reduce the risk of patient harm due to cybersecurity vulnerabilities. Intended as a recall, the corrective action is recommended to protect patients from cybersecurity exploits and intrusions, some which could affect how the device operates. While there are confirmed vulnerabilities, there are no known reports of cybersecurity-related harm with regard to the 465,000 devices currently implanted in the U.S. The firmware update must be administered in person by a health care provider. Prophylactic removal of the affected devices is not recommended by the FDA or Abbott.

Pacemakers manufactured after Aug. 28 will already have the update installed and do not require any further action. For additional information, contact Abbott's hotline at 1-800-722-3774. Read the full FDA announcement here.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Computer Security, United States Food and Drug Administration, Risk, Prostheses and Implants, Pacemaker, Artificial, Arrhythmias, Cardiac


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