Ev3 issued a recall of some dilatation catheters lots due to problems with the shaft of the device. The problem is that the catheter shaft could crack or break, leading to unplanned open surgery injury, infarct, bleeding and death. The notice of the recall was last month. For whatever reason, it is just getting reported now.
The product subject to the recall, the NanoCross .014″ OTW PTA dilatation catheter, is not an implant. It is a medical device used for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis to improve myocardial perfusion.
This dilation catherter is a Class I recall which is the opposite of the Lipitor recall I wrote about earlier this week. A Class I recall means the FDA is concerned that using these dilation catherters could cause serious adverse health consequences or death.