FDA approves cybersecurity patch for vulnerable pacemakers

More than 400,000 implantable pacemakers are being recalled for critical cybersecurity updates, the Food and Drug Administration (FDA) announced August 29.

The pacemakers, manufactured by Abbott Laboratories in Abbott Park, Illinois, formerly St. Jude’s Medical Devices, came under fire by the FDA in April for technical issues and cybersecurity vulnerabilities that could allow the devices to be hacked. The recall affects 465,000 individuals. Devices in the recall include:

• Accent
• Accent MRI
• Accent ST
• Allure
• Anthem
• Assurity

Patients do not need to have the devices removed but should consult with their providers about the risks of cybersecurity vulnerabilities and whether it’s appropriate to install the update based on case-specific risks and benefits, the FDA said. Although in some cases the update should be performed in a facility where temporary pacing can be provided, there is a low risk of device malfunction after installing the update, Abbott said in an August 28 statement.

Device settings should be recorded prior to the update in the event they must be reset. The installation process itself takes approximate three minutes. The device will operate in backup mode during that time.

Installation instructions and additional details are available for providers on the Abbott device programmer.

Visit Abbott’s cybersecurity update page or call 1-800-722-3774 for more information.