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Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Cathete...

FDA Device Recall #Z-1166-2024 — Class I — January 22, 2024

Recall Summary

Recall Number Z-1166-2024
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 3, 889 units

Product Description

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, 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: 222277587 00613994445407; 223565027 00763000624804; 223580362 00763000624804; 223698572 00763000624804; 223734523 00763000624804; 223999040 00763000406028; 224301720 00763000406028; 224302820 00613994445407; 224973997 00613994445407; 224990852 00613994445407; 224990870 00613994445407; 224990871 00613994445407; 225198822 00613994445407; 226490967 00763000624804; 226517899 00763000624804; 226546799 00613994445407; 226571115 00613994445407; 226665388 00763000624804; 226665395 00613994445407; 226734688 00763000624804; 226734689 00763000624804; 226756273 00763000406028

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-1163-2024 Class I Medtronic Duet External Drainage and Monitoring... Jan 22, 2024
Z-1164-2024 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.

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