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# FDA Clears New LiveNova System Version
- URL: https://www.fdaweb.com/fda-clears-new-livenova-system-version/
- Published: 2020-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:04:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146174

FDA says it cleared 2/25 a new version of the LivaNova heater-cooler system 3T that has changes to help reduce the risk of patient infections, including updated labeling with validated cleaning and disinfection instruction and the 3T aerosol collection set. Announcement of the clearance was included in an agency [safety communication](https://www.fda.gov/medical-devices/safety-communications/update-reduce-risk-cardiac-surgery-infection-while-using-livanova-heater-cooler-system-3t-fda-safety?ref=fdaweb.com) to remind healthcare providers and staff of ways to reduce the risk of cardiac surgery infection when using the LivaNova 3T system. The new communication updates a 10/2018 communication.

The 2018 notice said the company had issued a medical device correction letter giving updated instructions to monitor the concentration of hydrogen peroxide in the water circuit to verify that enough concentration is present to limit microbial growth and to announce the availability of the 3T aerosol collection set design upgrade to reduce, but not eliminate, the risk of potential emission of aerosols from the 3T system.

The latest safety communication contains recommendations for healthcare providers and staff.