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U.S. Department of Health and Human Services

Class 1 Device Recall CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 100 cm

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  Class 1 Device Recall CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 100 cm see related information
Date Initiated by Firm September 24, 2009
Date Posting Updated November 06, 2009
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-0084-2010
Recall Event ID 53576
510(K)Number K964161  K962510  K955132  
Product Classification Vascular Clamp - Product Code DXC
Product EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile
R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the
ascending aorta.

Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter 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 Model EC1001 (codes are recorded in the following format: Lot #/Expiration date): 581130/Aug-09; 582944/ Aug-09; 591423/Aug-09; 591424/Nov-09; 598990/Sept-09; 598992/Nov-09; 604411/Oct-09; 605844/Dec-09; 606674/Dec-09; 606676/Jan-10; 607104/Feb-10; 608371/Feb10; 608375/Feb-10; 608377/Feb-10; 608379/Mar-10; 618753/Mar-10; 623151/Mar-09; 624601/Mar-10; 624602/Apr-10; 628961/Apr-10; 628962/Apr-10; 630344/May-10; 634975/Jun-10; 634976/Jun-10; 643171/May-10;; 644544//Jun-10; 644545/Jul-10; 644546/Jul-09; 651860/Jul-10; 651861/Aug-10; 651862/Aug-10; and 651865/Sep-10. .
Recalling Firm/
Manufacturer
Edwards Lifesciences Research Medical, Inc.
6864 South 300 West
Midvale UT 84047
For Additional Information Contact Customer Service
800-424-3278
Manufacturer Reason
for Recall
Balloon catheters were spontaneously rupturing during use.
FDA Determined
Cause 2
Process control
Action Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions.
Quantity in Commerce 2,737 total
Distribution Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
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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