The Center for Disease Control and Prevention has warned that the Stockert 3T Heater-Cooler device places patients at risk for serious infection.

According to the Center for Disease Control and Prevention (CDC), patients who have undergone open heart surgery since 2012 may be at risk of a potentially fatal infection due to the use of a Stockert 3T Heater-Cooler device.

During this time, 28 heart surgery patients in the U.S. have been infected and at least 12 patients have died, the CDC reports.

“The overall risk is exceedingly low,” notes Dr. Vinod Thourani of the American College of Cardiology. Over the last four years, around 600,000 patients have been placed at risk of infection in this manner, resulting in only 28 reported infections.

Indeed, the CDC has estimated that the risk of a patient being infected in this way at a hospital where this has occurred is somewhere between one in 100 and one in 1,000.

What is the Stockert 3T Heater-Cooler Device?

The Stockert 3T Heater-Cooler device, manufactured by LivaNova PLC, is a device used during heart surgeries to warm and cool a patient’s blood and organs as necessary.

However, the CDC warns that during the manufacturing process, each Stocker 3T Heater-Cooler device may have been contaminated with a bacterial species of nontuberculous mycobacterium (NTM).

An NTM infection carries specific symptoms, including night sweats, aching muscles, joint pain, weight loss, fatigue, and fever.

Symptoms can take months to surface after initial infection, which often means that patients have no idea what caused the problem in the first place. This can lead to missed or delayed diagnosis for up to several years.

This is a serious pulmonary illness that, even with antibiotic treatment, can take over a year to subside.

It’s important to note that NTM is not a contagious disease, and cannot spread from person to person. And though heart surgery is certainly one possible way for a patient to be infected from NTM, it can also come from elsewhere in the environment.

From January 2010 to August 2016, 91 reports of infections associated with the Stocker 3T Heater-Cooler device have come in from across the globe. 79 of these infections were confirmed.

After a 2015 report from Swiss investigators showed a link between heart surgery patients and NTM infection, both the CDC and the U.S. Food and Drug Administration published alerts about the Stockert 3T Heater-Cooler device and others like it. Similar cases have since been identified in Pennsylvania, Iowa, and Michigan.

Stockert 3T Heater-Cooler Device Lawsuits

A class action lawsuit against LivaNova over the Stocker 3T Heater-Cooler device complications was filed in February 2016 in Pennsylvania. The patients involved in the class action suit had undergone open heart surgeries in 2015.

If you or someone you love has suffered from a NTM infection after undergoing heart surgery with the use of a Stockert 3T Heater-Cooler device, you may be able to file a lawsuit or join a class action lawsuit.