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U.S. Department of Health and Human Services

Class 2 Device Recall CardioVations Endoclamp(TM) Aortic Catheter

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  Class 2 Device Recall CardioVations Endoclamp(TM) Aortic Catheter see related information
Date Initiated by Firm November 26, 2008
Date Posted January 05, 2009
Recall Status1 Terminated 3 on August 10, 2011
Recall Number Z-0644-2009
Recall Event ID 50502
510(K)Number K964161  
Product Classification Vascular Clamp - Product Code DXC
Product Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
Code Information Lot numbers: MS0408007, MS0508033, MS0508040, 561241, 562406, 567576, 569133, 569134, 569135, 575695, 579683, and 581317.
Recalling Firm/
Manufacturer		 Edwards Lifesciences Research Medical, Inc.
6864 South 300 West
Midvale UT 84047
For Additional Information Contact
801-565-6195
Manufacturer Reason
for Recall		 Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at 801-565-6173.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled "PRODUCT RECALL." Questions could be referred to the Edwards representative or call 800-424-3278.
Quantity in Commerce 1267 units
Distribution Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.
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 = HEARTPORT, INC.
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