Z-2412-2023Class II

Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular...

Name: Z-2412-2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular...
Creator: Medtronic Neurosurgery
Published: 2023-06-28
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2023-06-28 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Neurosurgery began a recall of Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only on 2023-06-28. FDA classified it as Class II and gives the reason as "Product labeling contains incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2412-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-28
Posted: 2023-08-17
Recalling firm: Medtronic Neurosurgery
Product: Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Product labeling contains incorrect expiration date
Root cause tag: labeling and UDI
FDA root 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 [email protected] " 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.
Product codes and lots: Lot # 226632942; UDI-DI: 00763000624781

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2412-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2412-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-17

Product code JXG

K984053Class IIBecker External Drainage and Monitoring SystemMedtronic PS Medical / cleared 1999-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)