ev3 receives Class I notice for US catheter recall
This article was originally published in Clinica
Executive Summary
The US FDA has given ev3’s recall of certain lots of its NanoCross .014" PTA balloon catheter as Class I notification – the most serious type of recall notice. The FDA action was prompted by a letter sent by ev3 to its customers in November that said there is potential for the device to crack during use. The Plymouth, Minnesota-based company said that breaking of the catheter shaft can result in its inability to inflate or deflate the balloon, thus possibly causing injury or death. The company has asked for all affected lots – manufactured from 27 May to 18 October 2010 – to be removed from use. The NanoCross catheter is designed to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal and renal arteries.