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U.S. Department of Health and Human Services

Class 1 Device Recall IntraClude IntraAortic Occlusion Device

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  Class 1 Device Recall IntraClude IntraAortic Occlusion Device see related information
Date Initiated by Firm May 14, 2019
Create Date June 11, 2019
Recall Status1 Open3, Classified
Recall Number Z-1705-2019
Recall Event ID 82870
510(K)Number K113182  K132175  K163693  
Product Classification Clamp, vascular - Product Code DXC
Product IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO

The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
Code Information Lot Numbers: 60972890, 61078031,  61097633,  61139239,  61259627, 61259628,  61713218,  61723505,  61898939
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact
949-250-6827
Manufacturer Reason
for Recall
Possibility of balloon rupture in some lots of the intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.
FDA Determined
Cause 2
Under Investigation by firm
Action On 05/14/19, the firm, Edwards, mailed "Urgent Product Recall" notices, via overnight service to its customers. The letter described the product, problem and actions to be taken. The letter informed customers of the recall and instructed them to do the following: 1) Review this field safety notice to understand the potential hazard. 2) Complete and return the attached Acknowledgement Form within five (5) business days of receiving this notice to Edwards Customer Service via Edwards Lifesciences LLC, email: cs.usfaxes@edwards.com or FAX (800) 422-9329. 3) Complete and return the Product Reconciliation Form to Customer Service; return affected devices with the Return Goods Authorization (RGA) provided. 4) Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. If you have further distributed this product, notify your customers to the user level. Report any balloon failures to the recalling firm. Customers with additional questions were encouraged to call Customer Service Monday through Friday at (800) 424-3278, Option 1, from 8:00 AM - 4:00 PM Pacific Time.
Quantity in Commerce 757
Distribution Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MO, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI; and countries of: United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, France, United Kingdom, Italy, Netherlands, Poland, Romania, and Sweden.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXC and Original Applicant = Edwards Lifesciences LLC
510(K)s with Product Code = DXC and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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