FDA Issues Corrective Recalls over St. Jude Pacemakers Cyber Security

Santa Clara, CA: The US Food and Drug Administration (FDA) has issued a recall specifically for corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers.

The firmware update will be available beginning August 29, 2017. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update.

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. 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.

Many medical devices, including St. Jude Medical's implantable cardiac pacemakers, contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.

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Published on Aug-29-17