Edwards Lifesciences recalls Sapien heart valve delivery system

Posted on August 22, 2019 by Medtech[y] Staff

Fresh off broadening the approval for TAVR in lower risk, healthier patients, The U.S. Food & Drug Administration announced the recall of Edwards Lifesciences' SAPIEN 3 Ultra delivery system after a number of balloons burst during implantation, leading to several injuries and a death.

The SAPIEN 3 Ultra delivery system is a part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. It is used to deliver and deploy the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards SAPIEN 3 transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.

What is TAVR?

The FDA has listed this as a Class I recall, which is the severest form of recall.

This recall affects all patients in the U.S. who had a transcatheter aortic valve replacement procedure using the Edwards SAPIEN 3 Ultra Transcatheter Heart System starting January 3, 2019.