Medtronic Neurosurgery Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Product labeling contains incorrect expiration date

Recommended Action

Per FDA guidance

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)