Urgent Safety Notice on PTA Balloon Dilatation Catheter product families (Models Coyote™ Over-The-Wire and Coyote™ Monorail™), Boston Scientific International
2014.02.14
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00615/14
Boston Scientific International has issued an urgent field safety notice on PTA Balloon Dilatation Catheter product families (Models Coyote™ Over-The-Wire and Coyote™ Monorail™). Such products may exhibit a balloon deflation failure. Boston Scientific is initiating a voluntary urgent device recall for two specific lots of such catheters.