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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Lifesciences IntraClude IntraAortic Occlusion Device

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  Class 2 Device Recall Edwards Lifesciences IntraClude IntraAortic Occlusion Device see related information
Date Initiated by Firm March 30, 2018
Create Date May 24, 2018
Recall Status1 Terminated 3 on November 29, 2023
Recall Number Z-1929-2018
Recall Event ID 79650
510(K)Number K163693  
Product Classification Clamp, vascular - Product Code DXC
Product Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100.

Designed to occlude the ascending aorta.
Code Information 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.
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 S Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact
801-565-6100
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers were notified on about 03/30/2018 via an Urgent Medical Device Safety Notice. Instructions included to review the field safety notice and understand the potential hazard, review the recall with appropriate clinical staff at their institution, complete and return the acknowledgement form, and distribute the notification within the organization where potentially affected devices may have been transferred. Questions can be directed to Edwards Customer Service, Monday through Friday at 800-424-3278 form 8:00 AM - 4:00 PM Pacific Time.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXC and Original Applicant = Edwards Lifesciences LLC
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