Reported May 30, 2018 · Terminated
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number:…
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 · 12050 S Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system
- Model NumberICF100. Designed to occlude the ascending aorta
- Lot codes and dates
Lot No. 60876468608508856060850886608508886085088960850890608872176088721860887219608872206093049460934623609346246093462560972889609728906097289261014406610144086101441061014411610501716105017261078031610780326109763361139239611392406113924161139242611849646118496567784966611849676120458661204587612596266125962761259628and 61259629
- Amount recalled
- 3,052 units total
Where it was sold
Why it was recalled
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
This product could cause temporary or reversible health problems — stop using it.
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