Edwards Lifesciences is recalling the SAPIEN 3 Ultra delivery system; the system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. The Food and Drug Administration has identified this as a Class I recall, meaning use of the device could cause serious injuries or death.
The SAPIEN 3 Ultra delivery system was distributed on January 3, 2019, so may affect patients who had a transcatheter aortic valve replacement procedure using the Edwards SAPIEN 3 Ultra Transcatheter Heart System from this date. The system was indicated for patients with severe, symptomatic, aortic valve stenosis.
The Company initiated the recall on July 8, 2019, after receiving reports of burst balloons during implantation procedures. Withdrawing a burst balloon from the patient may cause vascular injury, bleeding or necessitate surgical intervention.
At the time of the recall there were 17 injuries and 1 death reported.
Edwards Lifesciences sent an Urgent Field Safety Notice on July 9, 2019, warning physicians of the possibility of rupture and what to do in such cases. The full instructions can be read here.
For more information visit FDA.gov.