Contact Us

PW Case Review Form
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 


   * Please describe your case:

What injury have you suffered?

For verification purposes, please answer the below question:

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.

Edwards Lifesciences Recalls Aortic Catheters

Nov 10, 2009 | Parker Waichman LLP

Edwards Lifesciences Corporation has issued a recall of CardioVations EndoClamp Aortic Catheter.  The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall.  

The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.  According to the recall notice, the balloon catheters may spontaneously rupture during surgery.

The CardioVations EndoClamp Aortic Catheters subject to this recall include  Model Numbers EC1001 and EC65.  This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.

On October 29 , 2009, Edwards Lifesciences sent a letter to their customers instructing them to:

    Check their inventory and identify any unused product
    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 these products will cause serious adverse health consequences or death.

Related articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo