Heater-Cooler Devices: Side Effects, Recalls & Lawsuit Information
Heater-cooler devices were previously considered life-saving devices, but some models have caused some patients to develop life-threatening infections. This dangerous risk has led to warnings, safety communications, recalls and lawsuits.
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- Last update: November 24, 2025
- Est. Read Time: 4 min read
Key Takeaways
- A heater-cooler device is intended to protect patients by warming or cooling them during cardiothoracic surgeries.
- In 2015, an outbreak of the Mycobacterium chimaera bacteria was traced to certain heater-cooler devices, with most cases pointing directly to the LivaNova Stöckert 3T as the source of the contamination.
- FDA communications and recalls verified that some manufacturers failed safety requirements for these devices.
- Law firms are accepting cases from patients who were adversely impacted by heater-cooler devices.
In 2015, specific heater-cooler devices used for patients who had open-chest heart surgery caused a global outbreak of Mycobacterium chimaera. This led to severe infections, and some cases were fatal.
The Centers for Disease Control and Prevention (CDC) estimates that the affected device was previously used in 60% of the over 250,000 bypass surgeries performed annually in the United States.
The outbreak spurred the U.S. Food & Drug Administration (FDA) to take action. In the years that followed, there have been legal repercussions, recalls and heater-cooler device lawsuits.
What Is a Heater-Cooler Device?
A heater-cooler device is used during open-chest surgery to help keep blood and organs at the right temperatures. Given their ability to warm and cool patients, these medical devices are considered critical for life-saving surgeries.
Heater-cooler devices involve tanks that provide temperature-controlled fluids (normally water) to warming/cooling blankets or external heat exchangers. They are useful for cardiothoracic surgeries that include your heart and lungs.
These devices differ from consumer products like Dyson fans or fan coolers because they are Class II medical devices that require FDA reviews and clearance. Consumer fans and coolers are not subject to FDA oversight.
Heater-cooler devices come with unique medical risks, and some of these products have caused infections in patients due to bacterial contamination.
The issue with these devices lies in their use of water. Older HCUs circulated water through lines to a disposable heat exchanger. The integrated water reservoir would come to be identified as the likely source of infection.
Now, many medical institutions no longer use heater-cooler devices, while others have adopted revamped models that replace the use of water with a glycol-based heat transfer fluid (HTF).
Overall, heater-cooler devices were extremely popular for a long time before the risk of infection led to medical and legal complications.
What Infections Are Linked to Heater-Cooler Devices?
Heater-cooler devices are linked to nontuberculous mycobacteria infections caused by Mycobacterium chimaera. The onset and diagnosis of this infection can be delayed, sometimes by more than one year, because the bacteria can grow slowly and be difficult to identify in tests.
- Abdominal pain
- Cough with blood
- Fatigue
- Heat, pus or redness at the surgical site
- Joint pain
- Persistent cough
- Persistent fevers
- Muscle pain
- Nausea
- Night sweats
- Unexplained weight loss
- Unusual or increasing shortness of breath
- Vomiting
There is a high risk of death with Mycobacterium chimaera. Mortality rates range from 20% to 60% after cardiothoracic surgery.
One device, in particular, was linked to the global outbreak of the bacteria.
LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices were a go-to for many medical facilities until they were thought to be contaminated during the manufacturing process. This was a big issue because over 60% of surgeries that used a heater-cooler device used this particular model. There is an even higher usage rate for heater-cooler devices in pediatric cardiac surgeries.
Recalls and FDA Actions on Heater-Cooler Systems
The FDA has issued many communications, warnings and recalls about heater-cooler devices since 2015.
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2015
- Warning: The FDA issued a warning that heater-cooler devices may cause Nontuberculous Mycobacteria infections and provided recommendations to health care workers on ways to mitigate the risks.
- Warning: A warning letter was sent to Sorin by the FDA due to violations of the Quality Systems Regulation. This warning was specific to Sorin’s Heater-Cooler 3T thermal regulator device.
- Recall: A recall was initiated for Maquet’s Heater-Cooler Unit 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W due to an issue with the supply board.
- Recall: A recall for Sorin’s Stockert Heater-Cooler 3T, 120 V / 60 Hz was initiated due to possible colonization of bacteria if proper maintenance and disinfection protocols were not completed.
-
2016
- Safety communication: A safety communication was prepared by the FDA to provide new information and suggestions about Mycobacterium chimaera infections linked to the use of the Stӧckert 3T Heater-Cooler System in cardiothoracic surgery patients. This communication was later updated to include information on how to prevent the spread of infection.
- Recall: A recall was initiated for Terumo’s HX2" Temperature Management Systems heater-cooler device due to the distributor no longer selling the required sanitizer.
-
2018
- Safety communication: The FDA issued a safety communication to minimize possible cardiac surgery infection risks linked to the LivaNovaHeater-Cooler System 3T.
- Recall: A recall for Sorin’s Heater-Cooler System 3T 120V~/60Hz was initiated when the manufacturer realized the disinfectant/water preservative intended to disinfect the device to inhibit/limit the growth of micro-organisms might be ineffective due to a chemical reaction.
-
2020
- Safety communication: An updated safety communication was issued by the FDA with information about lowering the risks of infections related to the use of the LivaNovaHeater-Cooler System 3T.
- Safety communication: The FDA sent a letter to health care providers about Mycobacterium abscessus infections related to the use of the CardioQuip Modular Cooler-Heater Device in cardiothoracic surgery patients.
- Recall: A recall for the LivaNova (formerly Sorin) Heater-Cooler System 3T was initiated due to the inclusion of validated cleaning and disinfection protocols in the device’s updated operating instructions.
-
2021
- Safety communication: The FDA sent updated information to lower the chances of infection associated with heater-cooler devices by CardioQuip or Gentherm Medical LLC. This information also reinforced recall notices to stop using heater-cooler devices from Maquet and Terumo.
- Recall: CardioQuip issued a recall for its MCH-1000 Cooler-Heater due to a labeling update.
-
2022
- Warning: The FDA sent a warning letter to CardioQuip about its Modular Cooler-Heater Model MCH-1000 device (“MCH-1000 Device”) after inspections showed Quality Systems Regulation violations.
Heater-Cooler Device Brands Linked To Recalls
Various heater-cooler device brands used in surgeries have been recalled. However, the Mycobacterium chimaera outbreak was attributed to the Stockert Heater-Cooler 3T.
In 2015, Sorin, the device manufacturer, recalled the product since bacteria could colonize if users did not follow the instructions for disinfection and maintenance. Subsequent recalls followed in 2018 and 2020 due to issues with disinfecting solutions and instructions.
Other heater-cooler device brands linked to recalls include:
- CardioQuip
- Maquet
- Terumo
Heater-Cooler Device Lawsuits and Legal Claims
Many heater-cooler device lawsuits have been filed by patients and their families. LivaNova specifically has faced substantial litigation.
-
2017
- Robert Gerngross of Pennsylvania filed a complaint alleging that the Sorin 3T Heater-Cooler Device caused a potentially lethal non-tuberculous Mycobacterium bacterial infection after his 2015 open-chest surgery.
- Jeri Pickrell filed a class action lawsuit against LivaNova in the U.S. District Court for the District of Iowa, alleging exposure to potentially fatal bacteria from the 3T heater-cooler device during open-heart surgery. Edward Baker and Jack Miller filed a class action lawsuit in Pennsylvania against Sorin for their 3T Heater-Cooler System.
- Steven Foster filed a class action lawsuit in South Carolina against Sorin for the same device. He later withdrew his request.
-
2018
- Pickrell’s class action lawsuit was dismissed because she couldn’t prove she had been injured by the 3T Heater-Cooler System.
- Plaintiff Liric J. filed a lawsuit in Louisiana’s federal court on behalf of her daughter Symphony J. She alleged that the company’s heater-cooler device caused her daughter to develop a serious infection after the surgery.
- Joseph S. sued LivaNova in Tampa’s U.S. District Court, alleging that the company’s heater-cooler device caused a severe infection following his 2014 coronary artery bypass graft surgery. His wife, Pamela S., also filed for loss of consortium.
- U.S. Judicial Panel on Multidistrict Litigation consolidated 40 heater-cooler device cases from 21 districts into a single multidistrict litigation (MDL) in the Middle District of Pennsylvania.
-
2019
- LivaNova announced a $225 million settlement to resolve roughly 75% of the Sorin 3T lawsuits. This covered pending cases in the MDL, a federal class action lawsuit and some state lawsuits.
-
2024
- LivaNova reported they continue to be involved in 3T litigation pertaining to cases in the MDL, state court cases and lawsuits outside of the U.S., citing 65 filed and unfiled cases globally.
-
2025
- In February, LivaNova reported that they are still involved in 3T lawsuits related to cases in the MDL, state court cases and lawsuits outside of the U.S., citing approximately 60 filed and unfiled cases worldwide.
As of September 2025, one active heater-cooler lawsuit remained in the MDL. LivaNova’s earnings report for the second quarter of 2025 did not share how many active cases remain globally.
- The manufacturer knew or should have known about the contaminated machines but sold them anyway to hospitals and physicians.
- The manufacturer failed to withdraw the machine from the market, despite being aware of the contamination.
- The manufacturer did not warn hospitals and health care professionals about the contaminated machines and the need to continue using them.
Other arguments alleged that LivaNova failed to conduct reasonable safety tests, while neglecting to provide thorough instructions for their system’s disinfecting procedures.
Who May Qualify for a Heater-Cooler Device Lawsuit?
You may qualify to file a heater-cooler device lawsuit if you had cardiothoracic surgery where a heater-cooler device was used and you later developed Mycobacterium chimaera. Families of impacted patients might also be eligible to file a lawsuit.
Although many people were affected during the outbreak, this bacterium has extremely slow growth, so it can take months or even years for an infection to surface. That means cases may still be ongoing, depending on the extended effects that patients experience.
If you think you qualify for a heater-cooler system lawsuit, talk to a lawyer to discuss your case and determine your next steps. Drugwatch can connect you with an attorney who will provide a free, no-pressure consultation.
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