Boston Scientific recalls certain lots of its Lotus Valve System
Boston Scientific voluntarily recalled certain lots of its Lotus Valve System that were manufactured before March 2016.
The Lotus Valve System, used in transcather aortic valve replacements, is not yet FDA-approved.
The company sent a letter to hospitals and customers explaining that the recall was due to breaks in the release mandrel, a component of the delivery system. Mass Device first reported on the recall.
The release mandrel breaks led to three patients dying of catastrophic vessel trauma, according to Boston Scientific.
Since the company made a component change in March, it said it had not received reports of release mandrel breaks.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.