FDA Announces Firmware Update for Certain Abbott Cardiac Devices

Apr 18, 2018 - 02:50 PM
FDA product update

The Food and Drug Administration yesterday announced a firmware update to reduce the risk of rapid battery depletion and address cybersecurity vulnerabilities in certain Abbott devices that provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. The update applies to several families of Abbott (formerly St. Jude Medical) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, including certain devices included in a 2016 recall related to premature battery depletion. FDA recommends that all eligible patients receive the firmware update at their next regularly scheduled visit or when appropriate, depending on the preferences of the patient and physician. Firmware is a type of software embedded in the hardware of a medical device.

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