Shunt, Central Nervous System And Components
Neurology · 21 CFR 882.5550
Recent MDR events
25,418 adverse event reports on file
- SOPHY MINI PROG.VALVE/8.PRESS. ANTICHAMBERJul 31, 2026MalfunctionSophysa3001587388-2026-00074
- Strata®Jul 31, 2026MalfunctionMedtronic Dominicana9612501-2026-02084
- Strata®Jul 30, 2026InjuryMedtronic Dominicana9612501-2026-02067
- Strata®Jul 30, 2026InjuryMedtronic Dominicana9612501-2026-02068
- Ventricular CatheterJul 30, 2026InjuryMedtronic Dominicana9612501-2026-02069
- Strata®Jul 29, 2026InjuryMedtronic Neurosurgery2021898-2026-00002
- UNKNOWN CATHETERJul 29, 2026InjuryMedtronic Neurosurgery2021898-2026-00003
- POLARIS® SPVA KIT PREATTACHED / BO19-10Jul 28, 2026MalfunctionSophysa3001587388-2026-00072
- BioGlide®Jul 28, 2026MalfunctionMedtronic Dominicana9612501-2026-02041
- POLARIS® SPVA KIT PREATTACHED / BO19-10Jul 28, 2026MalfunctionSophysa3001587388-2026-00073
Event type breakdown
Most-reported manufacturers
Recalls
108 recall events for this product code
- Integra LifeSciences Corp. (NeuroSciences)Open, ClassifiedMay 13, 2026
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501.
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Z-2173-2026 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedJan 17, 2025
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0977-2025 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedJan 17, 2025
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0978-2025 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedJan 17, 2025
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0979-2025 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedJun 12, 2024
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for drain
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Z-2136-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedJun 12, 2024
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2137-2024 · View FDA record ↗ - Integra LifeSciences Corp.Open, ClassifiedJun 12, 2024
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally comp
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Z-2138-2024 · View FDA record ↗ - Natus Medical IncorporatedOpen, ClassifiedJan 4, 2024
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Z-0634-2024 · View FDA record ↗ - Natus Medical IncorporatedOpen, ClassifiedJan 4, 2024
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Z-0635-2024 · View FDA record ↗ - Medtronic NeurosurgeryOpen, ClassifiedAug 17, 2023
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Product labeling contains incorrect expiration date
Z-2412-2023 · View FDA record ↗
Registered firms
587 firms currently registered for this product code
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Christoph Miethke Gmbh & Co.kg
potsdam Brandenburg, DE
Integra Lifesciences Switzerland Sarl
Le Locle Neuchatel, CH
Isomedix Operations Inc.
Northborough, MA, US
Sterigenics Us Llc
Los Angeles, CA, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Integra Canada Ulc
Oakville Ontario, CA
Natus Medical Incorporated
SAN DIEGO, CA, US
Integra Lifesciences Corporation
Princeton, NJ, US
Pmc Smart Solutions, Llc
Shelbyville, IN, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Geodis
Sparks, NV, US
Christoph Miethke Gmbh & Co.kg
potsdam Brandenburg, DE
Medtronic Neurosurgery
Fort Worth, TX, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
510(k) clearances
259 clearances for this product code
- Integra Lifesciences Production CorporationJun 23, 2026
K261004 · Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)
- Brainspace, Inc.Dec 10, 2025
K251598 · Intellidrop
- SophysaNov 28, 2025
K250636 · Sophy Mini Monopressure Valve (SM1)
- Phasor Health, LLCNov 5, 2025
K252514 · EVAC-MRI
- Integra Lifesciences Production CorporationAug 8, 2025
K243531 · Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
- Integra Lifesciences Production CorporationAug 6, 2025
K243552 · Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
- SophysaJun 20, 2025
K242974 · External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
- Phasor Health, LLCJun 3, 2025
K243205 · EVAC