Codman & Shurtleff, Inc.
FDA adverse event reports naming Codman & Shurtleff, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CODMAN & SHURTLEFF, INC..
- Total reports
- 3,668
- Deaths
- 27
- Injuries
- 2,354
- Malfunctions
- 1,269
Reports per year
Source: FDA adverse event reports by year received, 2008–2022. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Shunt, Central Nervous System And ComponentsJXG1,422
- Drills, Burrs, Trephines & Accessories (Compound, Powered)HBF596
- Device, Monitoring, Intracranial PressureGWM489
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI265
- Neurosurgical PaddieHBA260
- Pump, Infusion, Implanted, ProgrammableLKK184
- Stripper, Vein, DisposableGAJ38
- Rongeur, ManualHAE35
- Dura SubstituteGXQ33
- Product code LMPLMP30
Recent recalls
- 2015-05-28TerminatedProcess control
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .
Needle is leaking from hub/needle cannula connection
- 2014-10-20TerminatedDevice Design
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
- 2014-10-20TerminatedDevice Design
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
- 2014-10-20TerminatedDevice Design
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
- 2014-08-12TerminatedDevice Design
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- 2014-08-12TerminatedDevice Design
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- 2014-08-12TerminatedDevice Design
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- 2014-08-12TerminatedDevice Design
Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- 2014-08-12TerminatedDevice Design
Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- 2014-08-12TerminatedDevice Design
Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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