A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients.
The Class 1 recall includes model numbers EC1001 and EC65 of CardioVations EndoClamp Aortic Catheters manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009. A Class 1 recall is the most serious type of recall the FDA can issue and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Customers of Edwards Lifesciences Corporation received letters about the recall urging customers to check their inventory for the recalled catheters and identify any unused products. The unused products should be returned to Edwards Lifesciences Corporation at 6864 South 300 West, Midvale, Utah, 84047.
Health care professionals and consumers are encouraged to report any adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.