Edwards Lifesciences Corporation, CardioVations EndoClamp Aortic Catheter
Recall Class: Class I
Initiated: September 24, 2009
Product: CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65
This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.
Use: The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
Recalling Firm: Edwards Lifesciences Corporation
6864 South 300 West
Midvale, Utah 84047
Reason for Recall: The balloon catheters may spontaneously rupture during surgery.
Public Contact: Customers may contact the company's Customer Service Organization at 1-800-424-3278, Monday through Friday, 6:00 a.m. - 4:30 p.m., Pacific Time.
FDA District: Denver
FDA Comments: On October 29 , 2009, the company sent a follow up letter to their customers instructing them to:
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.