Boston Scientific recalls heart valve product

Medical device company Boston Scientific is recalling a range of heart devices at its Galway plant after an issue was reported with the device’s locking mechanism.

The company announced that it is recalling its Lotus range of heart valve replacement products, which is used in a minimally invasive procedure to replace a valve in the heart.

The issue was caused by excess in the pin mechanism introduced during the manufacturing process, the company state.

The announcement caused Boston Scientific’s shares to fall sharply by 9%.

The company said it expects to return the Lotus devices to the European market and other regions in the fourth quarter. To remedy the issue Boston Scientific will also put in place a new final inspection process.

Startribune reported that one patient died following an attempt to implant a second device, after the first one failed.

Trish Backes senior communications manager at Boston Scientific’s cardiovascular and rhythm management business told Startribune: “All affected patients were successfully treated with another valve, except for one reported case where implantation of the second valve was associated with aortic dissection and subsequent death. There was one other adverse event reported; during that case, the valve could not be removed, it, and was secured in the descending aorta with no additional complications.”

Last October Boston Scientific suspended implants of its Lotus Edge device in Europe lover similar concerns. The company stated that it found a solution for the issue.