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 lumen allows monitoring of the aortic root pressure.
This recall has been terminated (originally issued November 6, 2009).
- Recall Initiated
- September 24, 2009
- Posted
- November 6, 2009
- Terminated
- April 25, 2012
- Recall Number
- Z-0085-2010
- Quantity
- 2,737 total
- Firm Location
- West Midvale, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Spontaneous balloon rupture during use of the product.
Distribution
Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
Lot / Code Info
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.
Root 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.