FDA issues recall for Sapien 3 Ultra delivery system in aortic stenosis

After issuing a recall for the Sapien 3 Ultra delivery system, from Edwards Lifesciences, in July 2019, the FDA now has categorized the recall as extremely serious, highlighting health risks associated with its use. There were 17 injuries and one death reported at the time. However the system will remain on the market. The Sapien 3 Ultra is used to deliver and deploy a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.

In July 2019, Edwards Lifecience 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 removing the delivery system from the market, but rather has issued updated instructions for use to its customers. According to the FDA, 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. The recall affects 1,585 heart valve delivery systems.

Comment: Last week, the company's Sapien 3 And Sapien 3 Ultra heart valves were approved by the FDA for patients at low-risk of death linked to such surgeries. The FDA uses the term "recall" when a manufacturer takes corrective action or removes a problematic medical device from the market and does not always mean that customers must stop using the product or return it to the company. According to analysts, the FDA's decision to classify the issue as a Class I recall, its most severe, should not be viewed as a new issue or an escalation of the problem.