Class I Recall of Cardiovations Endoclamp Catheters

Reed Miller

Disclosures

November 10, 2009

November 10, 2009 (Midvale, Utah) — Edwards Lifesciences is asking customers to return CardioVations EndoClamp aortic catheters, model numbers EC1001 and EC65 [1]. The balloon catheters, deployed to block the aorta and monitor aortic pressure during cardiopulmonary bypass procedures, may spontaneously rupture during the surgery.

On November 10, the FDA categorized the recall as class I, indicating a reasonable probability that the defective device could cause serious injury or death.

On October 29, the company sent a letter to customers asking them to return any unused inventory of CardoVations EndoClamps to the company. Edwards says it initiated the voluntary recall on September 29, and as of November 10, 87% of the affected product in the US is accounted for. The catheters were manufactured from August 2008 to August 2009 and distributed from November 2008 through September 2009.

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