Shunt, Central Nervous System And Components
FDA adverse event reports and recall history for shunt, central nervous system and components (product code JXG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 25,328
- Deaths
- 222
- Injuries
- 16,189
- Malfunctions
- 7,898
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-13Open, ClassifiedProcess control
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
Out-of-specification endotoxin result that did not meet the acceptance criteria.
- 2025-01-17Open, ClassifiedLabeling Change Control
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- 2025-01-17Open, ClassifiedLabeling Change Control
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- 2025-01-17Open, ClassifiedLabeling Change Control
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- 2024-06-12Open, ClassifiedProcess control
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
- 2024-06-12Open, ClassifiedProcess control
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 for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
- 2024-06-12Open, ClassifiedProcess control
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 compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
- 2024-01-04Open, ClassifiedProcess change control
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
- 2024-01-04Open, ClassifiedProcess change control
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.
- 2023-08-17Open, ClassifiedLabeling Change Control
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Product labeling contains incorrect expiration date
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