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 bypass operation. But, three deaths have been attributed to the devices and more than 20 complaints have been received. At issue is the possibility of a balloon used by the device rupturing during a procedure. The results of such a failure can be, and have been, catastrophic.
For its part, Edwards Lifesciences has said that it “takes the safety of patients very seriously” and that it is “collecting all products back from customers” as they investigate.
This is not the only recall initiated by Edwards Lifesciences this year and the most recent all seem to involve the risk of catheter balloon deflation or rupture. The Miller Balloon catheter, along with the Fogarty dilation catheter, both join the IntraClude device as Class I recalls as classified by the FDA. While no deaths have been reported as a result of the failure of these two products, an infant had to undergo an invasive surgical procedure to retrieve a failed balloon that detached from a catheter during treatment. That procedure, while serious, was ultimately successful.