Abbott’s issued a recall this week that will require 465,000 pacemaker patients to visit their doctor or hospital for an update on a cybersecurity problem.
The cardiac pacemakers and cardiac resynchronization therapy (CRT-P) devices covered in the recall are Accent; Anthem; Accent MRI; Accent ST; Assurity; and Allure, all made by St. Jude Medical, which combined with Abbott’s in January.
As explained in an FDA alert, internet connections make modern pacemakers vulnerable to hacking. A hacker could speed up or slow down the pacemaker or even just drain the battery faster than usual.
So, Abbott’s came up with firmware to deal with the problem. All pacemakers manufactured from Monday on will include this firmware.
“The firmware update requires an in-person patient visit with a health care provider,” the notice states. “The update process will take approximately 3 minutes to complete. During this time, the device will operate in backup mode (pacing at 67 beats per minute), and essential, life-sustaining features will remain available. At the completion of the update, the device will return to its pre-update settings.”
The FDA recommends pacemaker possessors check with their doctors before getting the update. Those with questions can also go to sjm.com/cyberupdate or call Abbott’s hotline at 800-7322-3774.