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The CDC And FDA Working Together To Prevent Further Infection From Medical Device


The CDC and FDA have issued an advisory to hospitals, asking them to notify patients who underwent open-chest surgery involving a Stöckert 3T heater-cooler due to a possible contamination of a deadly infection. Last year, a Pennsylvania hospital identified a cluster of invasive NTM infections among patients who had undergone open-heart surgery. Cases in Iowa and Michigan have also been confirmed.

The CDC has asked hospitals that use this device currently or in the past to communicate with potentially exposed patients. The CDC is also asking hospitals with a history of using the device to increase awareness among healthcare providers.

The devices causing the infection have been linked to a manufacturer, LivaNova PLC. These devices were likely contaminated with the rare bacteria Mycobacterium during manufacturing. Delays in diagnosis can further complicate a patient’s clinical management. Therefore, the CDC and the FDA are working together to spread awareness and work to inform providers and patients about the risk of infection associated with the use of the 3T device.

Providers and patients should be notified that symptoms take months to show. Diagnosing the infection can be difficult and requires special analysis. Many of these types of infections are easily untreated and worsen a patient’s chance of battling the infection. The CDC has a complete list of symptoms that patients and providers should look for. To find out more about this contamination and who is at risk, visit the CDC or FDA websites.

If you are burdened with significant medical debt after battling an infection you contaminated at a hospital, medical facility, or use of a medical device, please contact a medical malpractice attorney at Meyerkord & Kurth, LLC, and let us help you recover financially.

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