LivaNova (NSDQ:LIVN) this week released a field safety notice it sent to customers with its FlexTherm heater cooler device informing them it is voluntarily removing all such devices installed at customer sites over design issues.
The company said it “conducted a thorough review” of the FlexTherm’s design and concluded that “the design concept does not fully meet user requirements.”
The U.K.-based company told customers with the devices that there is “no evidence to suggest that immediate removal from service is necessary,” and suggested that the devices could be used as normal until they are removed.
LivaNova said it is recalling all serial numbers under product code 16-17-00, and that company distributor representatives would be in contact to arrange for disposal of the affected devices.
Last October, the U.S. Centers for Disease Control & Prevention 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.
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.
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.
Although some patients died, it’s unclear how many were infected and whether infection was a direct cause of death, the agency said.