The United States Food and Drug Administration announced on Monday that they have classified a voluntary recall of Edwards Lifesciences Corp heart devices as Class I after three deaths were associated with the defective devices. Class I is the most urgent recall issued by the FDA, reserved for defective devices that can cause serious injury or death. The Edwards Lifesciences recall affects more than 750 heart devices in the United States.
Recalled Heart Device: IntraClude Intra-aortic Occlusion Device
The IntraClude intra-aortic occlusion device is used in patients undergoing cardiopulmonary bypass. The device temporarily takes over the function of the heart and lungs during surgery. The devices were recalled after the company received 22 complaints associated with a balloon rupture during use.
“Edwards takes the safety of patients very seriously”, said Sarah Huoh, a spokeswoman for the company, “As we look into this matter further, we are collecting all products back from customers.”
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