AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I ...
[Posted 01/05/2011] AUDIENCE : Risk Manager, Cardiology ISSUE : The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element …