medical Class II Updated 2019-04-17

Edwards Lifesciences, LLC recalls Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusio

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215
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