The recall of Edwards Lifesciences Corp’s Sapien 3 Ultra delivery system was categorized by the U.S. health regulator. Even though there are extremely serious health risks associated with its use, the products will remain in the market. To replace a diseased aortic valve without open-heart surgery, this system is used to deliver and deploy a transcatheter heart valve.
In July, a safety notice was sent to customers and doctors from the medical device maker stating that to avoid rupture
the balloon in the delivery system should be inflated slowly and continuously when deploying the heart valve. The company reported that it has issued updated instructions for use to its customers, but it is not pulling the delivery system from the market. The term ‘recall’ is used by the Food and Drug Administration (FDA) when a corrective action or removal of a problematic device is done by the manufacturer from the market. A recall will not always mean that the customers must stop using it or return the product to the company.
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, reported the agency. After receiving reports of 17 injuries and one death, Edwards started taking action in July. The FDA said that the recall has affected 1,585 heart valve delivery systems.
Jefferies analyst Raj Denhoy said in a note that the decision was taken by the FDA to classify the issue as a Class I recall, it’s most severe. It should not be perceived as a new issue or an escalation of the problem, instead, it is an acknowledgement of its severity. The agency approved the company’s Sapien 3 and Sapien 3 Ultra heart valves for use in patients at low risk of death linked to such surgeries.