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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Medtronic Duet External Drainage and Monitoring system, Interlink Injection sites, VentricularCather see related information
Date Initiated by Firm June 28, 2023
Date Posted August 17, 2023
Recall Status1 Open3, 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 2
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 and Original Applicant = MEDTRONIC PS MEDICAL
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