CDC: Infection Risk for LivaNova Heater-Cooler Devices for Heart Surgeries

Larry Hand


October 13, 2016

ATLANTA, GA — The Centers for Disease Control and Prevention (CDC) has issued a warning for healthcare providers and patients to be aware of a potential risk of infection from certain devices used during many open-heart surgeries.

In a news release issued today[1], the CDC said new information indicates that some LivaNova (formerly Sorin Group Deutschland) Stöckert 3T heater-cooler devices might have been contaminated by bacteria during manufacturing.

The device is used in about 60% of more than 250,000 heart bypasses performed in the US every year, according to the CDC. The agency put the chance of a patient getting the infection at between one in 100 and one in 1000 at hospitals where at least one infection has been identified. Patients with valve replacements or prosthetic products implanted are at higher risk.

While some patients in the CDC investigation have died, it is not clear whether the deaths resulted directly from the infection.

Today, the Food and Drug Administration updated its prior safety communication on the heater-cooler system with information on the implicated pathogen and recommendations on preventing its spread.

The bacterium, Mycobacterium chimaera, is a species of nontuberculous mycobacterium found in soil and water. M chimaera normally doesn't make healthy people sick, according to the CDC, but patients exposed during open-heart surgery can develop general and nonspecific symptoms over a period of months or years. Even after lab culture tests, it can take up to 2 months to rule out infection.

The CDC's Morbidity and Mortality Weekly report today has details of recently completed lab tests by the CDC and National Jewish Health[2].

Both the CDC and the Food and Drug Administration have warned about the heater-cooler devices before.

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