Devices

Device Recall Edwards Lifesciences IntraClude IntraAortic Occlusion Device

Model / Serial
Lot No. 60876468, 60850885, 6060850886, 60850888, 60850889, 60850890, 60887217, 60887218, 60887219, 60887220, 60930494, 60934623, 60934624, 60934625, 60972889, 60972890, 60972892, 61014406, 61014408, 61014410, 61014411, 61050171, 61050172, 61078031, 61078032, 61097633, 61139239, 61139240, 61139241, 61139242, 61184964, 61184965, 67784966, 61184967, 61204586, 61204587, 61259626, 61259627, 61259628, and 61259629.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Product Description
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. || Designed to occlude the ascending aorta.
Manufacturer
Edwards Lifesciences, LLC
1 Event
- Recall of Device Recall Edwards Lifesciences IntraClude IntraAortic Occlusion Device

Manufacturer

Edwards Lifesciences, LLC

Manufacturer Address
Edwards Lifesciences, LLC, 12050 S Lone Peak Pkwy, Draper UT 84020-9414
Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
Source
USFDA

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