FDA Recalls CardioVations EndoClamp Aortic Catheter
Monday, November 16th, 2009
The U.S. Food and Drug Administration (FDA) and Edwards Lifesciences notified health care professionals, Nov. 9, about the Class 1 recall of CardioVations EndoClamp™ Aortic Catheter, model numbers EC1001 and EC65. The recall was initiated because the balloon catheters may spontaneously rupture during surgery.
This product was manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009.
The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
On Oct. 29, 2009, the manufacturer sent a follow-up letter to their customers instructing them to:
- Check their inventory and identify any unused product; and
- Return unused products to the company.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product 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 this product to the FDA’s MedWatch Adverse Event Reporting program.