FDA WARNS: Nearly a half million
pacemakers vulnerable to hackers
The FDA Tuesday announced the recall of 465,000 pacemakers
Tuesday the FDA released a recall notice issued to those who currently have a pacemaker manufactured by the Abbott (formerly St. Jude Medical). A firmware update is now available as an emergency corrective action, to quickly reduce the risk of patient exploitation.
Who’s at risk?
* Patients with a radio frequency (RF)-enabled St. Jude Medical implantable pacemaker
* Caregivers of patients with an RF-enabled St. Jude Medical implantable cardiac pacemaker
* Cardiologists, electrophysiologists, cardiothoracic surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems using an RF-enabled St. Jude Medical implantable cardiac pacemaker
Vulnerable St. Jude Medical pacemaker and CRT-P devices :
What to do
If you’re affected by this recall, the firmware update requires in in-office visit your health care provider for an update. The process takes less than 5 minutes to complete, during which time, pacemakers will operate in backup mode (67 beats per minute). The FDA ensures that all essential, and life-sustaining features will remain available. When the update is complete the device will return to pre-update settings.