Reported Apr 17, 2019 · Ongoing
Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long…
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- 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 functionsaccommodating 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
- Lot codes and dates
70 of 70 codes
608508866085088860850885608508896085089060876468607609656088721760887219608872206093462360887218609346246093049460934625609728896097289060972892610144066101440861014410610144116105017161050172610780326107803161097633611392406113923961139241611392426118496561184964611849666118496761204586612045876125962661259627612596286125962961288501613692146136921561369216613692176142573261425734614257336149569261517743614956936153165361531655617045426153165461704656617132056171320661713208
- Amount recalled
- 2715 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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