USFDA recalls Edwards Lifesciences heart valves delivery system linked to 1 death, 17 injuries

U.S: The U.S. health regulator on Thursday categorized the recall of Edwards Lifesciences Corp’s Sapien 3 Ultra delivery system as extremely serious, highlighting health risks associated with its use, but the products will remain on the market.

The system is used to deliver and deploy a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.

In July, the medical device maker sent a safety notice to customers and doctors, recommending that the balloon in the delivery system be inflated slowly and continuously when deploying the heart valve to avoid rupture.

The company said it is not pulling the delivery system from the market, but rather has issued updated instructions for use to its customers.

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The Food and Drug Administration uses the term “recall” when a manufacturer takes corrective action or removes a problematic medical device from the market. A recall does not always mean that customers must stop using the product or return it to the company.

The agency said balloons that have burst during implantation procedures resulted in significant difficulty in retrieving the valve into the catheter and withdrawing the system from a patient's body.

Edwards started taking action in July after receiving reports of 17 injuries and one death.