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Class I Recall Initiated for Aortic Catheter

Edwards Lifesciences Corporation notified its customers about a class I recall of its CardioVations EndoClamp Aortic Catheter. The devices involved in the recall were distributed from November 2008 through September 2009. The model numbers included in the recall are:


The EndoClamp catheter is an important piece of equipment used during heart bypass surgery. The device blocks the aortic artery, delivers the solution that stops the heart during surgery, and monitors the aortic blood pressure. The problem is identified as a potential for the balloon catheters to burst spontaneously causing catastrophic and life threatening emergencies.

Obviously, heart bypass surgery is risky enough without introducing a life-threatening defect to one of the key components. Due to the severe nature of the defect and the potentially grave situation that may develop, the recall is classified as a Class I, the most serious type of recall on dangerous medical devices.

Healthcare facilities that use this product should isolate the remaining devices and contact Edwards Lifescience Corporation immediately to find out how to return the product. The customer phone number is, at 1-800-424-3278.

If you lost a loved one during a heart bypass surgery, it may be a result of a defective product like the CardiVations EndoClamp Aortic Catheter. If you suspect that this device contributed to the death of your loved one, please contact the experienced product liability attorneys at Schlichter, Bogard & Denton, LLP who work with clients nationwide.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

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