Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Ca...
FDA Device Recall #Z-1164-2024 — Class I — January 22, 2024
Recall Summary
| Recall Number | Z-1164-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | January 22, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Neurosurgery |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 14,139 units |
Product Description
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Reason for Recall
Potential for catheter disconnection from the patient line stopcock connectors.
Distribution Pattern
Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Gabon, Germany, Ghana, Greece, Hong Kong, Iceland, Iran, Islamic Republic Of Ireland, Italy, Kazakhstan, Kuwait, Latvia, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
Lot / Code Information
Lot Number/GTIN: 221604935 00613994445384; 221827829 00613994445384; 222121359 00613994445384; 222125124 00613994445384; 222163140 00613994445384 222163787 00613994445384; 222163788 00613994445384; 222204095 00613994445384; 222204097 00613994445384; 222439027 00613994445384; 222439028 00613994445384; 222439029 00613994445384 222658560 00613994445384; 222658561 00613994445384; 222724791 00613994445384; 222724792 00613994445384; 222766469 00613994445384; 222766470 00613994445384; 222816525 00613994445384; 222817386 00613994445384; 222817387 00613994445384 223818451 00763000624781; 223818452 00763000624781; 223954944 00763000624781; 223956932 00763000624781; 224083877 00613994445384; 224303373 00613994445384; 224303374 00613994445384; 225336444 00613994445384; 225468102 00613994445384; 226242272 00763000624781; 226366038 00613994445384; 226420633 00613994445384; 226420634 00763000624781; 226490981 00613994445384; 226517901 00613994445384; 226546796 00763000624781; 226571114 00763000624781; 226625848 00763000624781; 226632942 00763000624781; 226634688 00763000624781; 226634689 00763000624781; 226634690 00763000624781; 226665393 00763000624781; 226665394 00613994445384; 226665399 00763000624781; 226665400 00763000624781; 226665401 00763000624781; 226665403 00763000624781; 226665404 00763000624781; 226665405 00763000624781; 226665646 00763000624781; 226665647 00763000624781; 226665648 00763000624781; 226665650 00763000624781; 226732001 00763000624781; 226899377 00613994445384; 226951465 00613994445384; 226951467 00613994445384; 226951468 00613994445384; 226951469 00763000396008; 227136777 00763000624781; 227188108 00763000624781; 227194735 00763000624781; 227194736 00763000624781
Other Recalls from Medtronic Neurosurgery
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0662-2025 | Class I | Exacta External Drainage and Monitoring System:... | Nov 1, 2024 |
| Z-0661-2025 | Class I | Becker External Drainage and Monitoring System:... | Nov 1, 2024 |
| Z-1165-2024 | Class I | Medtronic Duet External Drainage and Monitoring... | Jan 22, 2024 |
| Z-1166-2024 | Class I | Medtronic Duet External Drainage and Monitoring... | Jan 22, 2024 |
| Z-1163-2024 | Class I | Medtronic Duet External Drainage and Monitoring... | Jan 22, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.