External Cerebrospinal Fluid (csf) Diversion
Neurology · 21 CFR 882.5560
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Recent MDR events
29 adverse event reports on file
- DUET EDMSMar 12, 2026MalfunctionMedtronic, Inc.24578550
- DUET EDMSMar 12, 2026MalfunctionMedtronic, Inc.24578552
- DUET EXTERNAL DRAINAGENov 18, 2025MalfunctionMedtronic Mexico S. De R.l. De CvMW5178962
- EXTERNAL CEREBROSPINAL FLUID (CSF) DIVERJun 6, 2024MalfunctionMedtronic Neurosurgery19475524
- DUETMay 31, 2024MalfunctionMedtronic Neurosurgery19434751
- DUET®Apr 22, 2024MalfunctionMedtronic Ps Medical, Inc.19152246
- DUET®Apr 11, 2024MalfunctionMedtronic Ps Medical, Inc.19087291
- DUETApr 10, 2024MalfunctionMedtronic Ps Medical, Inc.19078961
- MEDRONIC EXTERNAL MONITORING FOR CSFApr 10, 2024InjuryMedtronic Mexico S. De R.l. De CvMW5153724
- DUETApr 3, 2024MalfunctionMedtronic19031339
Event type breakdown
Recalls
5 recall events for this product code
- Medtronic NeurosurgeryOpen, ClassifiedFeb 27, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1162-2024 · View FDA record ↗ - Medtronic NeurosurgeryOpen, ClassifiedFeb 27, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1163-2024 · View FDA record ↗ - Medtronic NeurosurgeryOpen, ClassifiedFeb 27, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrosp
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1164-2024 · View FDA record ↗ - Medtronic NeurosurgeryOpen, ClassifiedFeb 27, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrosp
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1165-2024 · View FDA record ↗ - Medtronic NeurosurgeryOpen, ClassifiedFeb 27, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1166-2024 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Dsv Contract Logistics
Tijuana Baja California, MX
Medtronic Neurosurgery
Fort Worth, TX, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Isomedix Operations Inc.
SAN DIEGO, CA, US
Plexus Manufacturing Sdn. Bhd.
Bayan Lepas Pulau Pinang, MY
510(k) clearances
2 clearances for this product code