Recall Notice: AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall

On January 5, 2011, AngioScore Inc. issued a recall of certain AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platforms manufactured by the company. The recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020. The devices are being recalled due to a design defect which can cause unintended fracture and peeling, resulting in fraying of the bond and/or detachment of the distal end of the scoring element. AngioScore Inc. is advising customer to immediately discontinue use of any recalled product. Not doing so may lead to retained device fragments or arterial injury that could lead to the need for surgical intervention or death. Click here for more information.