Class 1 Device Recall NeuroBalloon

• Date Initiated by Firm: July 02, 2010
• Date Posted: September 22, 2010
• Recall Status: Terminated on May 29, 2012
• Recall Number: Z-2425-2010
• Recall Event ID: 56190
• Product Classification: neurovascular catheter - Product Code HAO
• Product: Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
• Code Information: Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
• FEI Number: 1121308
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp; 105 Morgan Ln; Plainsboro NJ 08536-3339
• For Additional Information Contact: James Tillman; 609-936-2485
• Manufacturer Reason for Recall: Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
• FDA Determined Cause: Process design
• Action: All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.
• Quantity in Commerce: 338 units
• Distribution: Nationwide, Canada, Taiwan and to Integra, Australia.
• 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.