FDA: Abbott updates pacemaker firmware to address cybersecurity vulnerabilities

Editor's Note

The Food and Drug Administration (FDA) announced on August 29 that it had approved a firmware update that is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to cybersecurity vulnerabilities for certain Abbott (formerly St Jude Medical) implantable cardiac pacemakers.

Pacemakers manufactured beginning August 28, 2017, will have this update preloaded and will not need the update.

The firmware update requires an in-person patient visit with a healthcare provider, and will take approximately 3 minutes to complete. The FDA does not recommend prophylactic removal and replacement of the affected pacemakers.

Posted 08/29/2017] AUDIENCE: Cardiology, Surgery, Family Practice, Patient ISSUE: On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St.