FDAnews
www.fdanews.com/articles/134083-merit-recalls-prelude-short-sheath-introducer

Merit Recalls Prelude Short Sheath Introducer

February 7, 2011
Merit Medical has recalled certain lots of its Prelude Short Sheath catheter introducer after discovering the device tips may detach during use, which could cause arterial injury or hemorrhaging. Detached tips also may enter into the bloodstream and cause blood clots. The FDA has classified the recall as Class I.