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# Edwards Recalls Sapien 3 Delivery Device
- URL: https://www.fdaweb.com/edwards-recalls-sapien-3-delivery-device/
- Published: 2019-08-22T12:00:00.000Z
- Updated: 2026-09-15T01:45:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144829

Edwards Lifesciences has recalled its Sapien 3 Ultra Delivery System due to balloon bursts during surgery, which may result in vascular injury, bleeding, or necessary surgical intervention. The device is part of the Sapien 3 Transcatheter Heart Valve System, which is indicated for use in patients with severe, symptomatic, aortic valve stenosis. The use of the affected product may cause serious adverse health consequences, including death, a [recall notice ](https://www.fda.gov/medical-devices/medical-device-recalls/edwards-lifesciences-llc-recalls-sapien-3-ultra-delivery-system-due-burst-balloons-during-surgery?ref=fdaweb.com)says. Seventeen injuries and one death were reported when Edwards initiated a field corrective action last month, it says.