Boston Scientific Corp. has issued a worldwide voluntary recall for an older version of one of its most commercially promising devices, the Lotus transcatheter aortic heart valve replacement system, following the deaths of three patients.
The Aug. 1 recall affects about 250 Lotus valve systems that were manufactured before March 2016 but have not yet been implanted in patients. About 15 of the devices are in the U.S.
The recall doesn't raise safety concerns for valves that have already been implanted in patients' hearts. Rather, the flaw involves a component that may break when the device is being implanted; the component is not left inside the body after the procedure.
The problem with the component — called the "release mandrel" — was fixed in March. The company said it has received no reports of broken release mandrels since then.
Although most of the malfunctions were resolved by just removing the device and its deployment system from the body, there were three cases that resulted in what the recall notice called "catastrophic vessel trauma associated with patient death."
The recall isn't expected to have a material financial effect on the company, a Boston Scientific spokesperson said via e-mail.
The Lotus valve is commercially available in Europe but only offered through clinical trials in the United States.
It's part of a new wave of artificial heart valves that can be implanted without major surgery, because they're designed to fit inside narrow tubes called catheters that can be inserted into a blood vessel and advanced to the heart using the body's vascular system.