Class 2 Device Recall CerebroFlo EVD Catheter

• Date Initiated by Firm: April 10, 2026
• Date Posted: May 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2173-2026
• Recall Event ID: 98752
• 510(K)Number: K170599
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
• Code Information: Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp. (NeuroSciences); 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Sajeel Afzal; 1-640-2619909
• Manufacturer Reason for Recall: Out-of-specification endotoxin result that did not meet the acceptance criteria.
• FDA Determined Cause: Process control
• Action: Integra notified consignees on about 04/10/2026 via letter. Consignees at medical facilities were instructed to examine inventory for affected units, remove them immediately from service and quarantine them, forward the notification to those who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas, and complete and return the "Medical Facility Acknowledgement Form provided. Integra Customer Care will contact consignees who have noted affected product on hand and provide a Return Material Authorization (RMA) number and directions to return the affected product. Distributors were instructed to remove the product from further distribution, complete and return the Acknowledgement Form, check customer traceability records and notify them if they have any shipments of affected product, modify the acknowledgement form to provide to their customers, collect completed response forms and affected product from customers and report to Integra on distributor reply form. When the form is received, and it is noted that affected product is on hand, Integra Customer Care will contact distributors and provide a Return Material Authorization (RMA) number and directions to return the affected product.
• Quantity in Commerce: 40 packs (200 units)
• Distribution: US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).
• 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.

• 510(K) Database: 510(K)s with Product Code = JXG