Class 3 Device Recall AngioSculpt PTCA Scoring Balloon Catheter

• Date Initiated by Firm: November 13, 2007
• Date Posted: January 23, 2008
• Recall Status: Terminated on March 25, 2008
• Recall Number: Z-0591-2008
• Recall Event ID: 46149
• PMA Number: P050018
• Product Classification: Balloon Catheter - Product Code NWX
• Product: AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
• Code Information: Lot Number: F07090015
• Recalling Firm/ Manufacturer: AngioScore Inc.; 5055 Brandin Ct; Fremont CA 94538-3140
• For Additional Information Contact: 510-933-7904
• Manufacturer Reason for Recall: Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
• FDA Determined Cause: Process control
• Action: The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.
• Quantity in Commerce: 40 units
• Distribution: Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NWX