Aortic Catheters Recalled, May Burst During Surgery

CardioVations EndoClamp Aortic Catheters are the subject of an urgent safety recall because the balloons on the medical devices may suddenly burst during heart surgery, posing a risk of life-threatening injury to patients, the Food and Drug Administration said.

The FDA and Edwards Lifesciences Corp., the maker of the devices, ordered the Class I recall for CardioVations EndoClamp Aortic Catheter, model numbers EC1001 and EC65. A Class I recall is the most severe action the FDA can take to remove potentially dangerous products from the market and is reserved for cases in which there is a reasonable probability that use of the products will cause for serious injury or death.

Catheter Balloons May Spontaneously Burst

The recalled devices are balloon catheters used to block off the aorta, monitor aortic pressure, and when necessary, stop the heart during heart bypass surgeries, the FDA said. They were manufactured from August 2008 and August 2009 and distributed to hospitals and other healthcare settings between November 2008 and September 2009.

The devices were ordered recalled on September 24, 2009, but the FDA and Lifesciences has now sent a new warning notice to physicians and hospital administrators, advising them to check their inventories of catheters to identify any recalled products and return any of the unused products to the company.

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