In a regulatory filing earlier, Boston Scientific (BSX) disclosed that it has announced a voluntary removal of all Lotus Valve devices, including Lotus with Depth Guard, from global commercial and clinical sites due to reports of premature release of a pin connecting the Lotus Valve to the delivery system.

"As with the prior announced suspension of our Lotus Edge Valve System device, we believe that the issue is caused by excess tension in the pin mechanism introduced during the manufacturing process. We expect to bring the Lotus Valve platform back to market in Europe and other regions in the fourth quarter of 2017. We anticipate filing the U.S. PMA submission for the Lotus Edge Valve System, the next generation platform, in the fourth quarter of 2017, with a U.S. launch planned for mid-2018," Boston Scientific stated in its filing.

In pre-market trading, Boston Scientific shares are down about 8% to $23.20.