Edwards Lifesciences, LLC recalls Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long

Recalled April 17, 2019 · FDA recall Z-1100-2019 · Edwards Lifesciences

Hazard

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. · FDA Class II

Units

2715 units

Sold at

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, and United Kingdom.

Description

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.

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.

Manufacturer(s)

Edwards Lifesciences, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →