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DeLauro Calls for Unsafe Medical Device Used in Heart Procedures to Be Pulled from Market

October 17, 2016

WASHINGTON, DC (October 17, 2016) Congresswoman Rosa DeLauro (CT-03) today released the following statement on the link between a deadly bacterial infection and a medical device used in cardiothoracic surgery. Last week, the Centers for Disease Control and Prevention (CDC) released a report confirming that LivaNova’s Heater Cooler regulator device is causing, in some cases, fatal infections.

“The news that LivaNova’s medical device has been implicated in multiple Mycobacterium chimaera infections and at least nine deaths is deeply disturbing,” said DeLauro. “Given that multiple patients have been severely sickened, and even killed, I urge the FDA to immediately pull this product off the market until we can be sure that it is safe to use.”

“I am outraged that LivaNova’s device has remained on the market despite receiving multiple complaints of patient deaths since January 2014, warning letters from the FDA, and even restricted imports on the device because of violations found at its manufacturing facility,” continued DeLauro. “Patients undergoing life-saving operations, such as open heart surgery, should not have to worry that the devices used in their procedures will kill them. Sadly, LivaNova’s blatant disregard for the health and safety puts that lives as risk.”

From January 1, 2010, to February 29, 2016, the FDA received 180 incident reports related to the heater-cooler device, including infections in 16 U.S. hospitals in 10 states where at least 45 patients were infected and nine died.

DeLauro is a senior member on the subcommittee responsible for funding the FDA, which is overseeing the investigation of infections associated with heater-cooler devices.