When you make a product that’s designed to clamp down on the aorta and drip solution to stop the heart during cardiopulmonary bypass procedures, you really should have that product go through some ruthlessly insane levels of quality control. Then test the product again, retest it, and then test it some more.
Well, today’s FDA recall is for a product that does just that. The official CLASS 1 recall is for “Edwards Lifesciences CardioVations EndoClamp Aortic Catheter ” and is specifically targeting “CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65”.
The problem? According to the recall notice, “The balloon catheters may spontaneously rupture during surgery.”
Oh yeah. That’s FUBAR. Big time.
The recall was started by the company on September 24th, but the FDA just issued the public notice today.
The CLASS 1 bit on FDA releases is “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.”
If you have CardioVations EndoClamp Aortic Catheter Model Numbers EC1001 and/or EC65, you can “contact the company’s Customer Service Organization at 1-800-424-3278, Monday through Friday, 6:00 a.m. – 4:30 p.m., Pacific Time.”
