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Bacterial Infections in Heart Surgery Patients Linked to LivaNova Heater-Cooler Device: FDA

More than 500,000 patients who had open-heart surgery with a LivaNova heater-cooler device could be at risk for a deadly bacterial infection, according to the FDA.

More than 500,000 patients in the U.S. who had open-heart surgery involving the use of a LivaNova heater-cooler device could be at risk for a deadly bacterial infection, according to the U.S. Food & Drug Administration (FDA).

Free Confidential Lawsuit Evaluation: If you suffered an infection or other injury after undergoing surgery in which a heater-cooler device was used, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the Problem?

October 14, 2016 – Over the past year, at least 28 bacterial infections in patients undergoing open-heart surgery in U.S. hospitals have been linked to Stöckert 3T heater-cooler devices made by LivaNova PLC, according to the Washington Post. Infections have also been reported in Europe, with some patients diagnosed nearly 4 years after surgery.

In recent years heater-cooler devices have become a staple of life-saving surgeries because they help keep a patient’s organs and blood at a specific temperature during the operation. The devices are used in an estimated 250,000 heart-bypass surgeries in the U.S. annually, and about 60% of these procedures involve use of LivaNova’s Stöckert 3T.

The bacteria associated with the heater-cooler devices, known as nontuberculous mycobacteria (NTM), are commonly found in nature and aren’t usually harmful. However, NTM can cause severe infections in patients who have had invasive procedures, particularly when they have compromised immune systems.

Symptoms of NTM infection include night sweats, muscle aches, weight loss, fatigue or unexplained fever. Due to the generalized nature of these symptoms, diagnosis can be missed or delayed, making the infection more difficult to treat. Treatment involves a specific antibiotic regimen because standard antibiotics are ineffective against the bacterium.

Over the past year, the FDA and Centers for Disease Control and Prevention (CDC) have notified hospitals and doctors about the potential link between LivaNova heater-cooler devices and NTM infections. However, a recently completed genetic fingerprinting has provided the strongest evidence to date that the devices were contaminated at a single source — during their production in Munich, Germany. This means that many more heater-coolers could be contaminated than have been identified so far, placing thousands more patients at risk for life-threatening bacterial infections.

Do I Have a LivaNova Heater-Cooler Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in LivaNova heater-cooler lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Case Evaluation: Again, if you developed an infection or other injury after undergoing surgery with a heater-cooler device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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