Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.

Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.

The firm Edwards Lifesciences, disseminated the notices on 01/16/2019 by letter entitled "URGENT PRODUCT NOTIFICATION ACTION REQUIRED". The letter stated the problem, how to identify it, and actions to be taken. The customers were instructed to do the following: 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your institution. 3. Complete and return the acknowledgement form attached to this letter via fax to Fax: 949.250.2525 or email to www.edwards.com within five (5) business days of receiving this notice. 4. Distribute this notice within your organization or to any organization where the potentially affected devices may have been transferred. 5. Product may continue to be used. Product return is not required. If you have questions that have not been answered by this letter, please call Edwards Customer Service Monday through Friday at 949.250.2500.