What started out as a good week for the Lotus transcatheter aortic valve replacement (TAVR) valve was quickly derailed as manufacturer Boston Scientific voluntarily issued a mass recall of all Lotus devices.
The issue: a problem with of a pin connecting the valve to its delivery system. Operators had encountered the problem this fall in the next-generation Lotus Edge line of devices -- but Boston Scientific claimed to have fixed the issue .
Models with Depth Guard weren't spared from the recall. At the Cardiovascular Research Technologies meeting just this week, this new design change was found to reduce the need for TAVR patients to get permanent pacemakers, which had been the biggest weakness of the Lotus so far.
Yet a high rate of device repositioning prompted a session panelist to question whether there were problems with the valve.
Boston Scientific expects to reintroduce the Lotus to Europe and other regions in the fourth quarter of this year. That is when the company also expects to file an FDA premarket approval application for the Lotus Edge.
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