AngioScore has issued a recall for a very specific AngioSculpt Catheter: the AngioSculpt PTA Scoring Balloon Catheter, 0.018” OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. AngioSculpt Scoring Balloon Catheter is used in treatment of patients with peripheral arterial disease (PAD) and coronary artery disease (CAD).
This catheter was recalled after reports from the field of distal bond failure resulting in peeling of the bond and/or detachment of the distal end of the scoring element, wherein the proximal end of the scoring element remains secured to the catheter. I’m a lawyer; I’d be lying if I said I fully understood what that means at this point. But this is one thing I am sure about: this is a serious recall. There are an estimated 14,775 affected products that have been distributed in the United States and the FDA believes the use of this catheter may cause serious adverse health consequences that could be fatal.
Again the recall is very specific, and the FDA is clear that the recall does not affect the AngioSculpt PTCA catheters, or any AngioSculpt PTA catheter balloon sizes (in millimeters): 0.014” OTW, 2.0×10, 2.0×20, 2.5×20, 3.0×20, 3.5×20; or 0.018”OTW, 4.0×40, 5.0×40, 6.0×40.