Geez. http://www.ptca.org/news/2016/0803_BSX_LOTUS.html What is wrong with that industry and what the heck is wrong with fad. They have an issue leading to three reported deaths. Then they make a design change and have it approved, but recall the flawed devices only AFTER having approval. Wait, ... of course the design change had nothing to do with AEs. No further comment.
Boston Scientific 101: If a product isn't working out, sweep it under the rug, make some changes, and market it as a completely new product. Then quietly recall your "old technology."
Did something happen with Durata and the FDA that only you know about? Maybe you should blow the whistle. Idiot