Catheter, Ventricular
Neurology · 21 CFR 882.4100
Recent MDR events
157 adverse event reports on file
- VENTRICULAR CATHETER SET LUER CONNECTORJul 14, 2021MalfunctionIntegra Lifesciences Corporation12165600
- CODMAN CERTAS VALVESMay 29, 2020InjuryIntegra Lifesciences CorporationMW5094756
- INNERVISION SNAP SHUNT VENTRICULAR CATHETER KITMay 20, 2019DeathMedtronic Neurosurgery2021898-2019-00189
- NIJan 8, 2019InjuryCodman & Shurtleff, Inc.1226348-2019-10022
- INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STANDARD, 6CMJul 19, 2017InjuryMedtronic Neurosurgery2021898-2017-00387
- INNERVISION VENTRICULAR CATHETER, WITHOUT BIOGLIDE, BARIUM IMPREGNATEDApr 28, 2017InjuryMedtronic Neurosurgery2021898-2017-00244
- INNERVISION VENTRICULAR CATHETER, WITHOUT BIOGLIDE, BARIUM IMPREGNATEDApr 28, 2017InjuryMedtronic Neurosurgery2021898-2017-00243
- INNERVISION SNAP SHUNT VENTRICULAR CATHETER KITAug 17, 2016InjuryMedtronic Neurosurgery2021898-2016-00283
- INTEGRA-HERMETIC LARGE STYLE VENTRICULAR CATHETEROct 6, 2015MalfunctionIntegra NeurosciencesMW5056963
- HUMMINGBIRD VENTRICULARAug 12, 2015InjuryInnerspace Inc.5048851
Event type breakdown
Recalls
6 recall events for this product code
- Integra LifeSciences Corp.TerminatedApr 5, 2021
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephal
Incorrect labeling, Catheter did not have the required holes and markings
Z-1354-2021 · View FDA record ↗ - Vygon NeuroTerminatedJan 10, 2006
6 cm Catheter Reservoir with 10 cm extension
stylet in package is shorter than that claimed on the label
Z-0365-06 · View FDA record ↗ - Vygon NeuroTerminatedJan 10, 2006
7 cm Catheter Reservoir with 10 cm extension
stylet in package is shorter than that claimed on the label
Z-0366-06 · View FDA record ↗ - Vygon NeuroTerminatedJan 10, 2006
10 cm Scopable Catheter Reservoir
stylet in package is shorter than that claimed on the label
Z-0367-06 · View FDA record ↗ - Codman & Shurtleff, Inc.TerminatedJul 20, 2004
Codman Holter Salmon Rickham Reservoir with Ventricular Catheter
Drainage tips absent from catheter tip
Z-0772-04 · View FDA record ↗ - Integra Life Sciences Corp.TerminatedJul 20, 2004
Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set,
The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.
Z-1097-04 · View FDA record ↗
Registered firms
29 firms currently registered for this product code
Medtronic Neurosurgery
Fort Worth, TX, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Corona, CA, US
Sterigenics Us Llc
Los Angeles, CA, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Isomedix Operations Inc.
SAN DIEGO, CA, US
Integra Lifesciences Corporation
Princeton, NJ, US
Plexus Manufacturing Sdn. Bhd.
Bayan Lepas Pulau Pinang, MY
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Integra Lifesciences Switzerland Sarl
Le Locle Neuchatel, CH
Integra Canada Ulc
Oakville Ontario, CA
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Dsv Contract Logistics
Tijuana Baja California, MX
Cea Medical Manufacturing, Inc.
Colorado Springs, CO, US
Covidien
- Santo Domingo, DO
Christoph Miethke Gmbh & Co.kg
potsdam Brandenburg, DE
510(k) clearances
10 clearances for this product code
- Parker Hannifin Corp.Mar 27, 2017
K161731 · Cleveland Multiport Ventricular Catheter Set
- Mri Interventions, Inc.Aug 16, 2013
K123605 · SMARTFLOW CATHETER
- Codman & Shurtleff, Inc.May 14, 2003
K031123 · CODMAN BACTISEAL BARIUM STRIPED CATHETERS
- Bresagen, Inc.Aug 6, 2002
K021481 · BRESAGEN CATHETER, MODEL CS-3000
- Aesculap, Inc.Apr 5, 2002
K020728 · MIETHKE SHUNT SYSTEM
- Innerspace, Inc.Mar 8, 2002
K013005 · ACT 11 MP VENTRICULAR CATHETER
- Codman & Shurtleff, Inc.Oct 1, 2001
K003322 · CODMAN BACTISEAL CATHETERS
- Image-Guided Neurologics, Inc.Oct 25, 1999
K992796 · ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000