The U.S. Centers for Disease Control & Prevention yesterday warned of the risk of serious bacterial infection in open heart surgery patients patients from a device made by Sorin, which merged last year with Cyberonics to form LivaNova (NSDQ:LIVN).
The 3T heater-cooler device is used to maintain patients’ blood and organs at a specific temperature. The CDC said the devices may have been contaminated with Mycobacterium chimaera during their manufacture in Germany. About 150,000 U.S. heart bypass procedures, or roughly 60%, use the LivaNova 3T device annually, according to the CDC. That makes a recall unlikely given the sheer number of devices in use across the country, a CDC spokeswoman told Reuters.
“Taking them all out of service at 1 time wouldn’t really be an option to be able to continue to do those really critical and life-saving surgeries,” she said.
Symptoms of the infection include night sweats, muscle aches, weight loss, fatigue or unexplained fever and can take months to develop, further complicating the problem.
“Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them,” Michael Bell, deputy director of the CDC’s Healthcare Quality Promotion division, said in a statement.
Although some patients died, it’s unclear how many were infected and whether infection was a direct cause of death, the agency said.
“We are working with regulators to develop a solution that addresses their concerns and ensures continued clinician access to this important device, which enables lifesaving cardiac surgery,” LivaNova said.
The CDC and the FDA 1st warned about the potentially contaminated devices last year; the federal safety watchdog yesterday released updated guidance on preventing the spread of infections via the 3T device, as well as new information about Mycobacterium chimaera infections associated with the 3T device. A lawsuit brought in Pennsylvania alleges that the device exposed some 3,600 patients to the nontuberculous mycobacterium.
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