Cook Medical''s Formula(TM) Billary Stent Complaint
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Cook Medical''s Formula(TM) Billary Stent - Off Label Use in Kidney Causing Strokes
This device is not cleared by the FDA for use in the vascular system. It is designed to prop open the bile duct, yet doctors are mis-using it to open the artery leading to the kidney. This practice is being shown to cause coma, siezure and stroke due to an air embolism to the brain. Cordis Corporation has already recalled (Class I Recall) their Precise RX stent back in March of 2004.
On 52907 my mother was implanted with a Cook Formula 418 billary stent in the artery leading to her kidney which cased a severe stroke leaving half of her body paralyzed.
See www.cookmedical.com and www.fda.govcdrhrecallsrecall-050404.html
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