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Heater-Cooler Systems Face FDA Scrutiny

The agency has issued a safety alert on the risk of bacterial infections linked to the use of LivaNova/Sorin's heater-cooler units during open-chest surgery, and held an advisory panel meeting last week to discuss strategies to better ensure safety of these and similar devices.

FDA highlighted reports linking the Stockert 3T heater-cooler from LivaNova PLC/Sorin Group SPA with infectious disease in heart failure patients last week and also convened a public hearing on the safety of this type of device.

Infection with the M. chimaera bacterium following cardiothoracic surgery using the 3T has been reported in US patients, according to...

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