Some 3T heater-cooler devices manufactured by LivaNova, PLC may have caused dangerous and deadly Nontuberculous Mycobacteria (NTM) infections in many patients. 3T heater-cooler devices are used in cardiothoracic surgeries, which usually involve the heart, lungs, or esophagus. The common nature of these surgeries means that more than 500,000 patients may have a cause for concern. As a result, a 3-T Heater-Cooler class action lawsuit has been filed. Our law firm is talking to potential victims about joining the class action lawsuit (technically an MDL).
The Food and Drug Administration (FDA) started receiving reports about NTM infections caused by heater-cooler devices in 2010. “Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015.”
The FDA and the Centers for Disease Control and Prevention (CDC) have issued many alerts about this danger. In October 2016, the CDC issued an alert “warning healthcare providers and patients about the potential risk of infection from certain devices used during open heart (open-chest) surgery.” The warning followed new information indicating that some LivaNova Stöckert 3T heater-cooler devices “might have been contaminated during manufacturing.” Along with the alert, the CDC also issued several additional documents, including a heater-cooler notification toolkit, and questions and answers for hospitals and health departments. The FDA issued a similar alert in June 2016, and another in October of that year.