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: A Georgia LawyerFDA issues Class I recall of Edwards Lifesciences aortic catheter
The device is 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.
The recalled devices, model numbers EC1001 and EC65, were manufactured between August, 2008 and August, 2009 and distributed from November, 2008 through September, 2009.
Source here.
Full post as published by A Georgia Lawyer on November 13, 2009 (boomark / email).
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