AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter Recall

Washington, DCAngioScore 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.

Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death, or need for additional surgical intervention.

This 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 AngioSculpt PTA Scoring Balloon Catheter OTW 0.018" Platform is used for dilatation of lesions in the iliac, femoral, ilia-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.