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The Food and Drug Administration has announced on its website that medical device maker St. Jude Medical last month recalled a device used in heart surgery because of the risk that it could cause ...
The Trifecta (TM) Valve. (Photo: St. Jude Medical, Inc.) Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta ...
In the US, UK and the European Union, the most common type of artificial heart valve is the bioprosthetic valve. Mechanical valves are more commonly used in Asia and Latin America. [citation needed] Companies that manufacture heart valves include Edwards Lifesciences, [5] Medtronic, [6] Abbott (St. Jude Medical), [7] CryoLife, [8] and LifeNet ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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St. Jude Children's Research Hospital is a pediatric treatment and research hospital headquartered in Memphis, Tennessee. Founded by entertainer Danny Thomas in 1962, it is a 501(c)(3) designated nonprofit medical corporation which focuses on children's catastrophic diseases, particularly leukemia and other cancers. [ 1 ]