Government Regulators Warn About Contaminated Devices

The Food and Drug Administration (FDA) and Center for Disease Control (CDC) have warned that a device commonly used during some types of major heart, lung, and liver surgeries has been connected with very serious infections called nontuberculous mycobacteria (NTM) infections.1 These infections can cause serious illness, and even death.

The FDA and CDC are warning that the Sorin Stöckert 3T heater-cooler device might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections. In the United States, more than 250,000 heart bypass procedures are performed every year using heater-cooler devices, and the Sorin Stockert 3T Heater-Cooler Device is used in 60 percent of these surgeries. Government safety regulators have announced that the Sorin Stöckert 3T heater-cooler device has been associated with outbreaks of serious infections throughout the United States, Europe, and some other parts of the world.2

Robins Kaplan LLP is investigating cases in the United States where patients have developed NTM infections after use of the Sorin Stöckert 3T heater-cooler device.

How the Robins Kaplan team can help

At Robins Kaplan LLP, we investigate potential claims on behalf of patients who have developed an infection after open-heart surgery to determine whether they have a Sorin Stöckert 3T heater-cooler device lawsuit case. Our firm includes attorneys experienced in pharmaceutical lawsuits like ones against the manufacturer of the 3T device.  Our on-staff medical advisors, nurses, and lawyers are available to answer your questions and listen to your concerns as you determine what to do next. If you think you or a loved one has developed an infection after open-heart surgery, we are interested in hearing what you have to say.

For a free case evaluation, please contact us at 1.800.553.9910 (toll-free) or fill out this form. We handle cases in all 50 states. Our legal nurse consultants are standing by.

What is the 3T Stöckert 3T heater-cooler device?

During open-heart (open-chest) surgeries, heater-cooler devices are often used to regulate the body temperature, by warming up or cooling down patients. Heater-cooler devices are commonly used in surgeries involving the heart, lungs, esophagus, liver, and other chest surgeries, like coronary artery bypass grafting surgery (CABG), surgery for heart valve repair or replacement, and left ventricular assist device (LVAD) surgery. 

Research has shown that the water used in the 3T device may become contaminated. When the device is turned on, the bacteria can be released into the air through the device’s exhaust vent. When bacteria is released into the air during surgery, the bacteria can come in contact with patients, and an infection can occur.

The Infection Associated with the 3T Can Be Deadly

The Stöckert 3T heater-cooler has been associated with a type of bacteria called nontuberculous mycobacterium (NTM), specifically Mycobacterium chimaera (M. chimaera) as well as some other types of NTM.3 The M. chimaera bacteria are slow-growing – symptoms can develop a few weeks to up to 4 or 5 years after open-heart surgery. This type of infection is not generally tested for during routine testing for infection, and a specialized test must be used to determine if a patient has a NTM infection. Results from this specialized test can eight weeks or longer to identify the type of infection.

Symptoms of this serious infection are often general and non-specific, and may include:

  • Night Sweats
  • Unexplained fever
  • Muscle aches
  • Weight loss
  • Fatigue

Because symptoms can take months or years to develop, diagnosis of these infections can be missed or delayed, which makes the infections more difficult to treat.  The CDC reports that some patients have presented with a variety of problems, which may end up being diagnosed as this serious NTM infection, like:

  • Surgical site infection
  • Abscess
  • Endocarditis (infection of the inner lining of the heart)
  • Osteomyelitis  (infection of the bone)
  • Bacteremia (presence of bacteria in the bloodstream)
  • Hepatitis (inflammation of the liver)
  • Renal insufficiency
  • Splenomegaly (enlargement of the spleen)
  • Pancytopenia (reduction of red and white blood cells and platelets)
  • Granulomatous disease or sarcoidosis4

If the diagnosis is delayed, the infection can spread and become more difficult to treat.

What to do if you or your loved one suspects an infection

The CDC advises patients who have had open-heart surgery to seek medical care if they are experiencing the symptoms listed above. Many hospitals have notified patients that they may at risk for this infection.  Even if you have not received such a letter, you should seek medical care immediately if you suspect you have an infection and have had open-heart surgery over the past several years. The CDC has a “Sample Letter for Patients to Take to Their Primary Care Provider” available for you to download here.   

Contamination Found At Manufacturing Plant of the Sorin Stöckert 3T Devices

On June 1, 2016, the FDA issued a Safety Communication specific to M. chimaera infections associated with the use of the 3T.5  Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.

On October 13, 2016, the FDA issued an updated Safety Communication, which reported on testing from patients in Pennsylvania and Iowa where a cluster of M. chimaera infections was found.6 The testing found that the infections were associated with the Sorin Stöckert 3T Devices.

The Infection Outbreaks Associated with this Device Have Occurred Worldwide

The CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.  There are almost 2,000 of these devices at hospitals across the United States.7

As of October 2016, at least 28 cases of the M. chimaera infection have been reported in hospitals in the United States in Iowa, Michigan, and Pennsylvania, and at least six of these patients have died.8 As of November 2016, 52 people who have had open-heart surgery in Europe since 2011 have developed the M. chimaera infection, and 10 of these people have died.9  Cases have also been reported in Canada, Australia, and Hong-Kong.

Explore your right to compensation

If you or someone you know had open-heart surgery and developed an infection, you may have a claim against the Sorin Stöckert 3T Device manufacturer. Please contact us at 1.800.553.9910 if you want to investigate whether you could file a lawsuit against the Sorin Stöckert 3T Device manufacturer. Our dedicated team of attorneys is experienced in device-related lawsuits.

[1] See FDA and CDC websites on Heater-Cooler Devices and the ongoing investigation here: and
[2] Id. See also Rapid Risk Assessment by European Centre for Disease Prevention and Control:
[3] Id. [4] See Questions and Answers: Hospitals & Health Departments, available at
[5] Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH StÓ§ckert 3T Heater-Cooler System: FDA Safety Communication, available at
[6] UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) StÓ§ckert 3T Heater-Cooler System: FDA Safety Communication, available at
[7] CBS News, Contaminated Heart Surgery Devices May Post Infection Risk to Thousands, available at
[8] Id.
[9] Rapid Risk Assessment by European Centre for Disease Prevention and Control: