Invasive infections due to slow-growing nontuberculous mycobacteria, M. chimaera, have been identified in patients in Europe and the United States after open chest surgery using the LivaNova Sorin Stockert 3T (Sorin 3T) heater-cooler device. Heater-cooler devices are used in operating rooms with life-saving cardiopulmonary bypass machines to control core body temperature during open-chest cardiac surgery. The devices have closed water circuits that do not come into contact with patients. Sorin 3T heater-cooler devices manufactured prior to September 2014 may have been contaminated with M. chimaera during the manufacturing process. Investigation has confirmed that contaminated Sorin 3T heater-cooler devices can aerosolize and expose patients to M. chimaera during open chest surgical procedures. This webpage provides information for hospitals, clinicians and local public health officials, and links to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommendations. Patients seeking information should contact their medical provider or hospital.
The CDC will continue to work with the FDA and the clinical community to further evaluate and reduce the risk associated with these devices, as well as increase provider and patient awareness. Patients who have had open-heart surgery and are concerned about symptoms they may be experiencing should contact their health care providers. Clinicians with questions should contact CDC Info at 800-CDC-INFO (800-232-4636) or https://wwwn.cdc.gov/dcs/ContactUs/Form.