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SAPIEN 3 Ultra Delivery System Recalled over Concerns of Injury and Death

By Burg Simpson

heart valve surgery sapian 3 transcatheter aortic replacement

August 22, 2019   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

On August 22, 2019, the FDA reported that Edward Lifesciences, LLC recalled its SAPIEN 3 Ultra Delivery System due to reports of burst balloons during transcatheter aortic valve replacement surgery.

Transcatheter aortic valve replacement surgery is a minimally invasive procedure where the aortic valve is replaced using a catheter- a thin tube inserted into the blood vessels. The SAPIEN 3 Ultra Delivery System is a catheter that uses a balloon to deliver and deploy the replacement valve. According to the FDA, Edward Lifesciences, LLC has received reports of burst balloons during the transcatheter aortic valve replacement surgery, “which have resulted in significant difficulty retrieving the [artificial] valve into the catheter and withdrawing the system from the patients, which may cause vascular injury, bleeding, or surgical intervention.”

According to the FDA, this recall comprises 1,585 devices that were manufactured from January 23, 2018 through July 16, 2019.

If you or a loved one was injured by a burst balloon during transcatheter aortic valve replacement surgery, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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