Class 2 Device Recall Medtronic Duet External Drainage and Monitoring system, Interlink Injection sites, VentricularCather

• Date Initiated by Firm: June 28, 2023
• Date Posted: August 17, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2412-2023
• Recall Event ID: 92702
• 510(K)Number: K984053
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
• Code Information: Lot # 226632942; UDI-DI: 00763000624781
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 5290 California Ave; Irvine CA 92617-3073
• Manufacturer Reason for Recall: Product labeling contains incorrect expiration date
• FDA Determined Cause: Labeling Change Control
• Action: On June 28, 2023, Medtronic Neurosurgery issued a "Urgent: Medical Device Recall" Notification to affected consignees via FedEx and email. Medtronic asked consignees to take the following actions: 1. Immediately identify and quarantine unused affected products within your inventory. 2. Return the affected product per the return instructions listed in the Customer Confirmation Form. 3. Complete and return the Customer Confirmation Form, even if you do not have any affected product. 4. Share this recall notification with all who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 5. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and to the FDA MedWatch Adverse Event Reporting program via: " Contact Medtronic Customer Quality at rs.mnsprodexperiencehelp@medtronic.com " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm " FDA telephone at 1-800-FDA-1088 (1-800-332-1088)
• Quantity in Commerce: 44 units
• Distribution: US Nationwide distribution in the states of NJ, FL, CA, IL.
• 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