On Thursday, Boston Scientific Corporation issued a statement in which it recalled all of its Lotus Valve heart devices in Europe. This recall consists of both clinical and commercial sites. Also, the Lotus Valve has been removed from all clinical sites in the United States, where the valve is not yet approved for sale.
Overall, the recall is due to major manufacturing defects that have found to be present in the device.
The serious defects that has caused this recall are centered around a manufacturing problem that is linked to the premature release of the mechanism containing a pin that is used to implant the device into the heart in patients. The recall was made voluntary by the company. This is similar to mechanism issues that resulted in the Lotus recalls of 2014 as well as 2016.
This malfunction is only related to problems arising during the implanting of the device process and has not been found to negatively impact patients that have already had the procedure done. The recall does not impact individuals that have already been implanted with the device.
Furthermore, Boston Scientific Corp. has made it clear that that this recall will play a role in the delaying the United States launch of the device.
Also, as a result of the recall and pulling the current Lotus device, Boston Scientific Corp. has seen its shares sink, allowing rival companies such as Edwards Lifesciences and Medtronic to see success. Edwards Lifesciences and Medtronic makes similar types of heart valves of those produced by Boston Scientific Corp.
As of Thursday, Boston Business Journal reported loses of $1.4 billion in market cap as a result of the recall.
Ultimately, Boston Scientific Corp. expressed that they “expect to bring the Lotus Valve platform back to the market in Europe and other regions in the fourth quarter of 2017.” Boston Scientific also shed light on the United States launch of the device. The U.S. launch that was expected to take place by the end of 2017 has now been pushed back and is now expected to take place in the middle of 2018, barring any other malfunctions and recalls.