Boston Scientific Voluntarily Recalls All Lotus TAVR Devices
February 23, 2017—In a Form 8-K report to the US Securities and Exchange Commission (SEC), Boston Scientific announced a voluntary removal of all Lotus transcatheter aortic valve replacement (TAVR) devices, including Lotus with Depth Guard, from global commercial and clinical sites.
According to Boston Scientific, the action is a response to reports of the premature release of a pin connecting the Lotus valve to the delivery system. As with the previously announced suspension of the Lotus Edge valve system device, it is believed that the issue is caused by excess tension in the pin mechanism introduced during the manufacturing process, advised the company.
Boston Scientific stated in the SEC filing that the company expects to bring the Lotus TAVR platform back to market in Europe and other regions in the fourth quarter of 2017. In addition, the company anticipates filing the premarket approval submission with the US Food and Drug Administration for the Lotus Edge valve system, the next-generation platform, in the fourth quarter of 2017, with a United States launch planned for mid-2018.