Heater-Cooler Lawsuit2018-10-01T21:04:22+00:00

Heater-Cooler Lawsuit Information: The Stӧckert 3T heater-cooler, a device used during surgery to keep patients warm or cool, has been associated with an increased risk of the life-threatening non-tuberculosis mycobacteria (NTM), specifically the Mycobacterium chimaera (M. chimaera) bacteria. The U.S. Food and Drug Administration (FDA) has received reports of patients being exposed to NTM when a contaminated Stӧckert 3T heater-cooler device was used during cardiothoracic surgery.

LivaNova is defending itself against 3T heater-cooler lawsuits that allege the company’s device places patients at risk for the NTM infection. Earlier this year, a heater-cooler lawsuit was filed in a Pennsylvania federal court that sought class-action status on behalf of at least 3,600 patients who had open heart surgery at Wellspan York Hospital or at Milton S. Hershey Medical Center from October 2011 to November 2015. (Heater-Cooler Lawsuit Case No. 1:16-cv-00260, U.S. District Court, Middle District of Pennsylvania)

If you or a loved one recently had cardiac surgery, plastic surgery, or other medical procedures involving the 3T heater-cooler device and suffered or died from an NTM infection, legal advice from an attorney experienced with heater-cooler lawsuits should be sought immediately. Wright & Schulte LLC, an experienced law firm focuses on obtaining justice and representing the victims of defective medical devices. If you or someone you love endured pain and suffering due to a 3T heater-cooler device, we urge you to contact Wright & Schulte LLC for a free, no obligation 3T heater-cooler lawsuit evaluation today.[cdc.gov/hai/pdfs/outbreaks/cdc-notice-heater-cooler-units-final-clean.pdf, CDC, 8-26-16]

In December 2015, the FDA sent a warning letter to the Sorin Group Deutschland GmbH (Sorin) about its Stӧckert 3T heater-cooler device. The Italy-based Sorin is also known as LivaNova PLC after a 2015 merger with Houston, Texas-based Cyberonics Inc. FDA officials inspected LivaNova’s facilities in Munich, Germany and Arvada, Colorado in August and September 2015. The FDA’s warning letter outlined violations found at the facility in Germany that included failure to adequately validate and verify procedures for cleaning and disinfecting heater-cooler devices. The FDA told LivaNova it was taking steps to refuse entry of the devices made at the Munich facility into the United States. LivaNova said it was “taking these matters seriously” and is working to resolve violations of the FDA regulations.[fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm, FDA, December 29, 2015] [globenewswire.com/news-release/2016/01/05/799648/0/en/LivaNova-PLC-Provides-Update-on-FDA-Warning-Letter.html, LivaNova, January 5, 2016]

Heater-cooler devices are used during cardiothoracic and other surgeries to keep patients warm or cool. The devices include water tanks that provide temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits. Patients do not come into direct contact with water in the circuits however, contaminated water can potentially enter other parts of the device or transmit airborne bacteria through the device’s exhaust vent into the environment and to the patient. NTM infections are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure, according to the FDA.[fda.gov/medicaldevices/safety/alertsandnotices/ucm466963.htm, FDA, October 15, 2015]

Hospitals Alert Patients Of Possible Heater-Cooler Infections

In February, the University of Iowa Hospitals and Clinics sent letters to 1,700 patients warning them that they may have been exposed to NTM during heart, lung and liver surgeries. WellSpan York Hospital in York, Pennsylvania confirmed 11 patients with NTM infection, six of whom have died. Last year, Milton S. Hershey Medical Center in Pennsylvania sent 2,300 letters to patients. The hospital has identified three infected patients, two of whom have died.[yorkdispatch.com/story/news/health/2015/11/20/ntm-bacterial-infection-outbreak/75918984/, York Dispatch, November 20, 2015]

Signs and symptoms of Heater-Cooler NTM infection include a combination of the following:

  • Fever
  • Pain
  • Difficulty breathing
  • Pus, heat, redness at the surgical site
  • Night sweats
  • Joint pain
  • Muscle pain
  • Weight loss
  • Fatigue
  • Nausea
  • Vomiting
  • Death

Free Case Review

Wright & Schulte LLC Offers Free Heater-Cooler Device Lawsuit Evaluations

The attorneys of Wright & Schulte LLC work every day to preserve the rights of personal injury victims, one case and one client at a time. If you or a loved one recently had cardiac surgery or other medical procedures involving the 3T heater-cooler device and suffered or died from an NTM infection, and you’re looking for a personal injury law firm that will guarantee the caring, personalized and loyal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. For a free, no obligation legal 3T heater-cooler lawsuit evaluation of your case, simply fill out the online form on the right, or give Wright & Schulte LLC a call, toll-free, at 1-800-399-0795.


For a free, no obligation legal evaluation of your case, simply fill out the online form on the right, or give Wright & Schulte LLC a call, toll-free, at 1-800-399-0795.