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.
The Food and Drug Administration uses the term “recall” when a manufacturer takes a 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. (bit.ly/2MzmXuG)
Edwards started taking action in July after receiving reports of 17 injuries and one death.
The recall affects 1,585 heart valve delivery systems, the FDA said. However, Edwards said the recall was immaterial to the company’s revenue forecast.
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, rather it is an acknowledgement of its severity, Jefferies analyst Raj Denhoy said in a note.
Last week, the company’s Sapien 3 And Sapien 3 Ultra heart valves were approved by the agency for use in patients at low-risk of death linked to such surgeries.
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