Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA 92614-5686" 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA 92614-5686" 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
Brand
Edwards Lifesciences Research Medical, Inc.
Lot Codes / Batch Numbers
Model EC65 (codes are recorded in the following format: Lot #/Expiration date): 610810/Feb-10, 638667/Jun-10, 643626/Jun-10, and 651863/Aug-10.
Products Sold
Model EC65 (codes are recorded in the following format: Lot #/Expiration date): 610810/Feb-10; 638667/Jun-10; 643626/Jun-10; and 651863/Aug-10.
Edwards Lifesciences Research Medical, Inc. is recalling EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STER due to Spontaneous balloon rupture during use of the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Spontaneous balloon rupture during use of the product.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026