FDA recalls Edwards aortic catheter for spontaneous ruptures

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The FDA and Edwards Lifesciences of Irvine, Calif., have issued a Class 1 recall of CardioVations EndoClamp aortic catheter, a balloon device that blocks the aorta and monitors aortic pressure during cardiopulmonary bypass procedures.

The recall of Model Numbers EC1001 and EC65 was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August 2008 through August of this year and distributed from November 2008 through September of this year.

According to the agency, 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.”