Following nearly two dozen reports involving problems with IntraClude Intra-Aortic balloons, resulting in serious injuries and deaths, a recall has been issued due to a risk the device may rupture or puncture during cardiopulmonary bypass procedures.
The FDA announced an Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device recall on July 1, warning that three patients have already died because of the balloons bursting during heart surgery procedures.
The IntraClude Intra-Aortic Occlusion Device is a balloon used in patients undergoing cardiopulmonary bypass heart surgery, when a machine takes over the function of the heart and lungs temporarily. During surgery, the balloon is inflated, blocking and venting the aorta.
The recall comes after the manufacturer determined the balloon could rupture during use, which can result in extended surgery time, neurological damage, embolism, stroke, and death.
To date, the manufacture warns there have been at least 22 reports specifically involving balloon ruptures or punctures. Three patients have died as a result.
The FDA has classified the action as a Class I recall. It is the most serious type of recall and means the agency believes problems with the device pose a serious risk of resulting in injury or death to the patient.
The recall is for the IntraClude Intra-Aortic Occlusion Device model ICF100, UDI code (01) 00690103190007 and lots 60972890, 61078031, 61097633, 61139239, 61259627, 61259628, 61713218, 61723505, and 61898939.
The products were distributed from May 1, 2017, to February 19, 2019. The voluntary recall was first initiated by Edwards on May 14, 2019.
Edwards Lifesciences issued an Urgent Recall Notification to customers. The notice advised medical professionals of the risk and potential hazard. It also called on customers to stop using the device and return an acknowledgment form to the company within five business days.
The notice also calls on medical institutions to report the number of devices still in the customers possession and return the affected devices to Edwards Lifesciences.
For more information about the recall, contact Edwards Customer Service at (800) 424-3278. Adverse events or injuries should be reported to the FDA’S MedWatch Adverse Event Reporting Program.