Boston Scientific Corporation ($BSX) announced that it plans to recall its Lotus Valve devices due to reports of a premature release of a pin connecting the valve to the delivery system. The problem is most likely caused by excess tension in the pin mechanism introduced during the manufacturing process. The company will recall all the Lotus products including Lotus with Depth Guard.
The products will be excluded from global commercial and clinical sites, which may cause delay in such ongoing trials.
Boston Scientific plans to receives-introduce the devices back on the market in Europe and other regions in fourth quarter of the current year. The company also plans to file a PMA for its next-generation Lotus Edge Valve System in the United States. The market launch is expected to happen by the mid of next year.
Boston Scientific’s Lotus Valve system is designed for patients who can’t get valve replacement during open heart surgery, with the stent inserted through an incision in the leg.
The company stock slumped on the news. However, the price is still on the steady ground as the stock is up over 42 percent in the past 12 months. Its year to date gain stands at 13 percent.