FDA Medical Device Recalls (openFDA)
Medtronic Neurosurgery: Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
- Recall number
- Z-2412-2023
- Recalling firm
- Medtronic Neurosurgery
- Product
- Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
- Status
- Open, Classified
- Initiated
- 2023-06-28
- Posted
- 2023-08-17
- Terminated
- not on file
- Reason
- Product labeling contains incorrect expiration date
- 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 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
- 44 units
- Distribution
- US Nationwide distribution in the states of NJ, FL, CA, IL.
- Lot, serial or model codes
- Lot # 226632942; UDI-DI: 00763000624781
- 510(k) numbers
- K984053
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 3015531529
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28