Edwards Lifesciences' IntraClude Intra-Aortic Occlusion recall
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Why was Edwards Lifesciences' IntraClude Intra-Aortic Occlusion 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 3,052 units total
- 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.
- Recall date
- May 30, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)