More than 750 Edwards Lifesciences Corp IntraClude intra-aortic occlusion heart devices have been recalled in what the FDA has deemed a Class I recall. The Class I recall is the agency’s strictest and most dire recall warning and indicates that the continued use of the recalled product could cause serious injury or death.
The IntraClude was designed to serve as the patient’s heart and lungs during a cardiopulmonary ...
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