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AngioSculpt Recalls Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter Legal News Articles & Interviews

AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter Recall

January 5, 2011. By Lucy Campbell.
Washington, DC AngioScore Inc is recalling AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018" Platform (multiple sizes). The device recall has been initiated because 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. AngioScore Inc. sent Medical Device Recall notification letters to all domestic customers on Nov. 15, 2010 by overnight mail. The recall letters list the affected product with description, part numbers and that all lots are affected. They describe the reason for recall and the potential harm to patients.
Read [ AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter Recall ]


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