AngioScore recall gets class I notification
This article was originally published in Clinica
Executive Summary
AngioScore’s recall of its AngioSculpt balloon catheter has been given a class I notification by the US FDA. The firm recalled the AngioSculpt EX percutaneous transluminal coronary angioplasty (PTCA) scoring balloon catheter in December 2009 because it may become separated during use. This could allow fragments of the catheter to become lodged in coronary arteries, leading to serious injury or death. The affected lot of AngioSculpt EX balloon catheters was distributed by the Fremont, California-based company from 30 January until 4 December 2009. AngioSculpt catheters are used to dilate narrowed coronary arteries and improve blood flow to the heart muscle.