Class 2 Device Recall HALO360 Ablation Catheter

• Date Initiated by Firm: September 18, 2008
• Date Posted: October 31, 2008
• Recall Status: Terminated on April 26, 2011
• Recall Number: Z-0192-2009
• Recall Event ID: 49515
• Product Classification: Catheter filter - Product Code GEI
• Product: Hydrophobic HALO360 Filter that is; packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
• Code Information: Filter Lot number 78156 was packaged with Catheter Lot numbers: F1012714 , F1012715 , F1012716 , F1012718 , F1012721 , F1012723 , and F1012724, and/or with Sizing Balloon Lot number: F1012719.
• Recalling Firm/ Manufacturer: Barrx Medical, Inc.; 540 Oakmead Pkwy; Sunnyvale CA 94085-4022
• For Additional Information Contact: 408-745-8000
• Manufacturer Reason for Recall: Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
• FDA Determined Cause: Mixed-up of materials/components
• Action: The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.
• Quantity in Commerce: 650 units
• Distribution: Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
• 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.