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01-09-2011, 12:00 PM #1
AngioScore Incorporated Announces Worldwide Voluntary Field Removal of the AngioSculp
On November 15, 2010 AngioScore Incorporated, Fremont, CA initiated a worldwide recall of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018” OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. This recall was initiated because of a small number of reports from the field of distal bond failure which has resulted 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.