Boston Scientific Recalls 250 Lotus Valves Due to Delivery Error

Boston Scientific has recalled several lots of its Lotus Valve System due to breaks in the delivery system’s release mechanism, which have resulted in three deaths from catastrophic vessel trauma. “This action is related to potential breakage of the release mandrel on Lotus Valve Systems which were manufactured prior to March of 2016,” according to a Boston Scientific spokesperson. “The release mandrel is a component of the delivery system that is connected to the release pin which facilitates the release of the valve. The delivery mechanism has been corrected in manufacturing and devices made after March are not impacted by the recall.

The company says 250 units are being recalled. The malfunction has also led to the need for resheathing and device removal, resulting in longer procedure times. Because the problem is isolated to device delivery, there are no safety concerns for patients who already have an implanted device.