Class 2 Device Recall IntraClude(TM) IntraAortic Occlusion Device

• Date Initiated by Firm: January 16, 2019
• Create Date: April 06, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1100-2019
• Recall Event ID: 81928
• 510(K)Number: K163693
• Product Classification: Clamp, vascular - Product Code DXC
• Product: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device ; ; is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. ; ; The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.
• Code Information: 60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• Manufacturer Reason for Recall: Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
• FDA Determined Cause: Process control
• Action: The firm Edwards Lifesciences, disseminated the notices on 01/16/2019 by letter entitled "URGENT  PRODUCT NOTIFICATION  ACTION REQUIRED". The letter stated the problem, how to identify it, and actions to be taken. The customers were instructed to do the following: 1. Review this field safety notice to understand the potential hazard. 2. Meet and review with appropriate clinical staff at your institution. 3. Complete and return the acknowledgement form attached to this letter via fax to Fax: 949.250.2525 or email to www.edwards.com within five (5) business days of receiving this notice. 4. Distribute this notice within your organization or to any organization where the potentially affected devices may have been transferred. 5. Product may continue to be used. Product return is not required. If you have questions that have not been answered by this letter, please call Edwards Customer Service Monday through Friday at 949.250.2500.
• Quantity in Commerce: 2715 units
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, France Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, UAE, 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 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