Medical Device Safety and Recalls: Updated Safety Communication on Mycobacterium chimaera Infections associated with LivaNova PLC Stӧckert 3T Heater-Cooler System

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Updated Safety Communication on Mycobacterium chimaera Infections associated with LivaNova PLC Stӧckert 3T Heater-Cooler System

The FDA has issued an updated Safety Communication on Mycobacterium chimaera Infections associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System.

The FDA updated its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices.

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