Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Edwards recall: Models of Edwards Lifesciences' CardioVations EndoClamp aortic balloon catheters may spontaneously rupture during surgery, according to a Class I recall announcement from FDA. Edwards initiated the recall on Sept. 24 and sent a follow-up letter to customers Oct. 29 instructing them to check their inventory and return unused products to Edwards. The EndoClamp balloon catheter is used to block off the aorta, monitor aortic pressure and deliver a solution to stop the heart during cardiopulmonary bypass procedures. The two affected models of the device were manufactured from August 2008 through August 2009 and distributed through September 2009. Class I recalls are the most serious type