Heater-Cooler Devices: Use of Devices Associated With Nontuberculous Mycobacteria Infections

Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, the FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems. [10/20/15]