I received this notification (link) from Medscape regarding a Class I recall of the Angiosculpt balloon. I used it a handful of times in restenosis of bypass grafts and found it to work quite well. I did not see the device fragment, and certainly cutting balloons come with risks. I found under-sizing the device by about an mm or so worked well in dilating areas of neointimal hyperplasia. I never had the stones to use these on a calcified plaque in the iliac arteries. It’s too bad it has to be taken off the shelf. Anyone see vessel rupture or retained foreign bodies after using the Angiosculpt balloon angioplasty?
