If you have undergone heart surgery recently, chances are a Stockert 3T Heater/Cooler was used during their procedure. LivaNova PLC, the manufacturer of the 3T, controls roughly 60% of the market for such heating/cooling devices. During a cardiac surgery, the patient’s body temperature is regulated through the use of the 3T’s temperature-controlled water tanks while the heart is stopped. Such heater/coolers have been known to improve patient outcomes.
However, LivaNova is facing growing scrutiny as many patients have acquired life-threatening infections after their surgeries due to the 3T. This machine utilizes three water tanks to properly regulate the patient’s body temperature, and some of that water is released from the machine in the form of water vapor. When this happens, a strain of mycobacteria called Mycobacterium chimaera, which is commonly found in drinking water, can be blown into the air and land on the patient’s surgical wound or infect sterile equipment. This can cause an often-deadly infection called nontuberculous mycobacteria (NTM). It may take several months or years for the symptoms of the infection to appear, but once they do, the patient only has a 50% chance of survival. Anywhere between 1/100-1/1,000 patients will become infected during their heart surgery.
Immediately consult your cardiologist if you or someone you love has had heart surgery in the last several years and is now experiencing one or more of the following symptoms:
- Prolonged Fever
- Muscle or Joint Pain
- Nausea or Vomiting
- Redness or Pus around the Surgical Site
LivaNova issued a Class 2 recall for all of its 3T devices, acknowledging the risk of NTM infection in 2015. Later that same year, the FDA issued an import restriction on the 3T after inspections of LivaNova’s manufacturing facilities in Munich, Germany and Colorado. They were found to have violated FDA Quality Systems Regulations. The FDA has issued other warnings and consumer suggestions in the time since. Many hospitals have since sent warning letter to former patients apologizing for using the 3T during their surgeries and warning them of potential infection exposure. This response by hospitals was directed by the CDC via advisory notice, which you can read [HERE]