The Food & Drug Administration issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures.
The device, a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, “may spontaneously rupture during surgery,” according to the FDA recall. Class I recalls are the watchdog agency’s most serious, used when there’s a “reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recalled devices, model numbers EC1001 and EC65, were manufactured between August, 2008 and August, 2009 and distributed from November, 2008 through September, 2009. In a prepared statement, Edwards said it issued its own, voluntary recall Sept. 29 and sent a letter to customers a month later asking them to check inventory and return any unused products to the company.
Eighty-seven percent of the affected products in the U.S. have been accoutned for, according to the statement.
Edwards declined to reveal how many devices are affected by the recall, whether any adverse events were associated with the potential malfunction or to provide a copy of the letter it sent to customers.
The company posted net income of $74 million on sales of $326 million during the three months ended Sept. 30, gains of 123.4 percent and 7.3 percent, respectively, over the same period last year.