Recall Z-0084-2010

Edwards Lifesciences Research Medical, Inc. · initiated September 24, 2009

Terminated

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.

Codes / lots: 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.

Reason for recall

Balloon catheters were spontaneously rupturing during use.

FDA-determined cause: Process control

Action taken

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.

Details

Recall number
Z-0084-2010
Initiated
September 24, 2009
Posted by FDA
November 6, 2009
Terminated
April 25, 2012
Product code
DXC – Clamp, Vascular
Quantity
2,737 total
Distribution
Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
Recalling firm
Edwards Lifesciences Research Medical, Inc., Midvale, UT

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0085-2010 EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic…Spontaneous balloon rupture during use of the product. 09/24/2009Terminated