| Subject: | Class I Recall of Edwards Lifesciences CardioVations EndoClamp Aortic Catheter |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 10 Nov 2009 - 11:00 am |
| The Food and Drug Administration (FDA) and Edwards Lifesciences are notifying healthcare professionals about the Class I recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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