FDA Designates AngioSculpt Balloon Catheters Recall as Class 1

Cardiovascular Business -- The FDA has issued a Class I recall of AngioSculpt’s EX Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheters, after it was found that the devices may fragment and become lodged in a patient’s coronary arteries, resulting in serious injuries and even death.