Safety Alerts and Notifications
October 15, 2020
Safety Notice - FDA Alert
On September 30th, 2020, the U.S. Food and Drug Administration posted a letter to health care providers regarding reports of nontuberculous mycobacteria (NTM) infections in patients who had undergone cardiothoracic surgery involving the use of CardioQuip Modular Cooler-Heaters.
The letter can be found at the following link:
While the root cause of infection in these cases is not yet known and continues to be evaluated, the FDA provides general recommendations to reduce the risk of infection during cardiac surgery when using any heater-cooler device. We will update the community in the event that more information becomes available.