Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
Neurology · 21 CFR 882.4100
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Recent MDR events
44 adverse event reports on file
- VENTRICLEAR DRAINAGE CATHETER SETNov 12, 2025MalfunctionCook Inc1820334-2025-01401
- VENTRICLEAR¿Aug 20, 2025MalfunctionMedtronic Neurosurgery3015531529-2025-00002
- VENTRICLEAR VENTRICULAR DRAINAGE CATHETERApr 21, 2025InjuryCook IncorporatedMW5169351
- EXTERNAL VENTRICULAR CATHETERNov 4, 2024MalfunctionCook IncorporatedMW5162152
- VENTRICLEAR DRAINAGE CATHETER SETOct 7, 2024InjuryCook Inc1820334-2024-01304
- VENTRICLEAR¿Jul 23, 2024MalfunctionMedtronic Neurosurgery2021898-2024-00091
- VENTRICLEAR¿Jul 23, 2024MalfunctionMedtronic Neurosurgery2021898-2024-00092
- UNKNOWN VENTRICLEAR CATHETERFeb 15, 2022MalfunctionMedtronic Neurosurgery2021898-2022-00065
- VENTRICLEAR COOK CATHETER EVD 5 PKNov 2, 2020MalfunctionMedtronic Neurosurgery2021898-2020-00279
- VENTRICLEAR COOK CATHETER EVD 5 PKNov 2, 2020MalfunctionMedtronic Neurosurgery2021898-2020-00276
Event type breakdown
Recalls
2 recall events for this product code
- Cook Inc.TerminatedDec 14, 2015
VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
Z-0416-2016 · View FDA record ↗ - Cook Inc.TerminatedUnknown
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Z-2791-2018 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Cook IncorporatedApr 8, 2016
K160223 · VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
- Cook, Inc.Jul 12, 2007
K071640 · VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
- Cook, Inc.Nov 8, 2001
K011812 · SPECTRUM VENTRICULAR CATHETER