Aortic Balloon Catheter Recall: May Rupture During Surgery

A Class I recall has been issued for Edwards Lifesciences CardioVations EndoClamp Aortic Catheters, which are used during heart bypass surgery. The FDA and device manufacturer indicate that the balloon catheters may rupture during surgery, potentially causing a fatal injury for the patient.

The aortic balloon catheter recall was announced by the FDA and Edwards Lifesciences on Monday for devices manufactured between August 2008 and August 2009, which were distributed between November 2008 and September 2009.

The FDA classified the action as a Class I recall, which represents the most serious type of medical device recall. Although no information was provided by the FDA about any reports of injuries or deaths associated with the defective balloon catheters, Class I recalls are issued in situations where there is a reasonable probability that use of the recalled product will cause serious injury or death.

The recall applies to Edwards Lifesciences CardioVations EndoClamp Aortic Catheters model numbers EC 1001 and EC65. The balloon catheters are used during heart bypass surgery to block off the aorta. They also monitor aortic pressure and stop the heart during cardiopulmonary bypass operations.

Edwards Lifesciences sent a letter to their customers on October 29 instructing them to check their inventory and identify any of the unused recalled aortic balloon catheters impacted by this recall. Unused products should be returned to the company and any adverse events linked to problems with the catheters should be reported to the FDA’s MedWatch Adverse Event Reporting program.