AngioSculpt EX PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation
MedSun: Newsletter #53, October 2010
FDA MedWatch Safety Alert
The AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. This recall includes all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003. This product was distributed from January 30, 2009 through December 4, 2009. Customers should inspect their inventory for this recalled product and separate it from their inventory.
FDA MedWatch Safety Alert. AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation. September 8, 2010.