Class 2 Device Recall CODMAN CERTAS Plus Programmable Valves

• Date Initiated by Firm: December 16, 2024
• Date Posted: January 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0979-2025
• Recall Event ID: 95951
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
• Code Information: UDI-DI: 10381780535997. Lot Number: 7415567.
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Mary O'Neill; 1-640-8679411
• Manufacturer Reason for Recall: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• FDA Determined Cause: Labeling Change Control
• Action: Integra LifeSciences notified consignees on about 12/16/2024 via letter. Consignees were instructed to review and understand the information provided in the letter, complete and return the provided Customer Acknowledgement Form, remove any affected units from service and quarantine them, arrange for return of affected units, and forward the notification to anyone who utilizes the affected units. Distributors were instructed to follow the same directions but also requested to notify any customers if product was further distributed, and return affected units.
• Quantity in Commerce: 46 units
• Distribution: US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.