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FDA Announces Recall Of Boston Scientific’s Lotus Edge TAVR System

 
• By Shawn M. Schmitt

The US agency announced on 11 January a recall of the Lotus Edge transcatheter aortic valve replacement (TAVR) system – a device that Boston Scientific stopped making and voluntarily recalled two months ago.

Recall Road Sign against sky.

The US Food and Drug Administration announced on 11 January that Boston Scientific Corp. recalled its Lotus Edge transcatheter aortic valve replacement (TAVR) system. The agency affixed a high-risk class I designation to the recall.

Boston Scientific discontinued manufacture of the Lotus system in November and asked that any unused systems be returned to the company. There have been no reported injuries or deaths related...

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