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FDA alerts public to recall of pacemakers vulnerable to cyberattack

Staff Writer |
The Food and Drug Administration issued an alert for a voluntary recall of approximately 500,000 pacemakers that are vulnerable to being hacked.

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The company that makes the pacemakers, Abbott's - formerly known as St. Jude's - is recaling the devices "to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities," the FDA said.

The models of pacemakers and cardiac resynchronization therapy pacemaker devices affected by the recall include the Accent, Anthem, Accent MRI, Accent ST, Assurity and the Allure.

"The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment," the FDA said.

"This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing."

Despite the vulnerability detected, the FDA said there have been no known cases of any of these pacemakers getting hacked.

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