CODMAN HAKIM SIPHONGUARD 82-3162Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve In-Line Valve with SIPHONGUARD Device Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa -1960 Pa) Includes: Programmable Valve, Information Manual and Priming Adapter · Class 2 · Implant
All models of CODMAN HAKIM SIPHONGUARD (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704041559), received between Apr 12, 2022 and May 1, 2025 — classified as 12 injuries.
The most frequently reported specific device problem is “Pressure Problem” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Pressure Problem4
- Insufficient Device Problem Information3
- Obstruction of Flow3
- Infusion or Flow Problem1
- Insufficient Flow or Under Infusion1
- Positioning Problem1
Patient problems
- Insufficient Information7
- Failure of Implant2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cerebral Ventriculomegaly1
- Erythema1
- Headache1
- Local Reaction1
- Nausea1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2025Infusion or Flow Problem; Infusion or Flow Problem
InjuryJan 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryDec 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2024 DUE TO SHUNT DYSFUNCTION. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT PRESENTED SIGNS AND SYMPTOMS DUE TO SHUNT DYSFUNCTION. PRIMARY DISEASE: SLIT VENTRICLE SYNDROME.
Patient problems: Insufficient Information
MAUDE report 20926262 ↗InjuryOct 4, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2024-00306. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) AND A PERITONEAL CATHETER WERE IMPLANTED ON (B)(6) 2024 VIA VENTRICULOPERITONEAL (VP) SHUNT WITH UNKNOWN SETTING DUE TO CONGENITAL HYDROCEPHALUS. THE PATIENT DEVELOPED SLIT-LIKE VENTRICLES DUE TO UNDER DRAINAGE. CONTRAST EXAMINATION WAS PERFORMED AND COULD NOT CONFIRMED THE CEREBROSPINAL FLUID (CSF) FLOW AROUND PERITONEAL CATHETER DUE TO SHUNT DYSFUNCTION. THEREFORE, THE VALVE AND PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2024. THE PATIENT RECOVERED.
Patient problems: Insufficient Information
MAUDE report 20369197 ↗InjuryOct 4, 2024Pressure Problem; Pressure Problem
A PHYSICIAN REPORTED A HAKIM VALVE (ID (B)(6)) WAS IMPLANTED DUE TO NON-COMMUNICATING HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2019 WITH UNKNOWN SETTING. THE PRESSURE SETTING COULD NOT BE CHANGED; THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE ON (B)(6) 2024. THE PHYSICIAN PULLED OUT THE DEVICE AND DAMAGED IT DURING REVISION SURGERY. ACCORDING TO INFORMATION PROVIDED, THE INITIAL AND THE DESIRED SETTING ARE UNKNOWN. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO DEVICE ISSUE. THE PATIENT HAS RECOVERED.
Patient problems: Insufficient Information
MAUDE report 20369151 ↗InjuryJul 26, 2024Obstruction of Flow; Obstruction of Flow
InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJan 25, 2023Obstruction of Flow; Positioning Problem; Obstruction of Flow; Positioning Problem
InjuryDec 13, 2022Pressure Problem; Pressure Problem
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED, TO TREAT HYDROCEPHALUS. THE PATIENT'S BRAIN WAS FILLING UP WITH TOO MUCH CEREBROSPINAL FLUID (CSF) HOWEVER, THE SURGEON WAS UNABLE TO CHANGE THE SETTING TO RELIEVE THE FLUID. THE VALVE WAS REMOVED, AND IT IS UNKNOWN IF THE VALVE WAS REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15971908 ↗InjuryMay 25, 2022Pressure Problem; Pressure Problem
A PHYSICIAN REPORTED A PROG VALVE INLINE W SG (ID 823162) WAS IMPLANTED VIA V-P SHUNT OVER 10 YEARS AGO WITH 110 MMH2O. THE SET PRESSURE WAS NOT CHANGED, THEREFORE AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE FROM 110MM H2O TO 90 MM H2O, HOWEVER, IT COULD NOT BE CHANGED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO THE ISSUE.
Patient problems: Failure of Implant
MAUDE report 14497755 ↗InjuryMay 13, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (B)(6) WAS IMPLANTED IN A (B)(6) MALE PATIENT VIA V-P SHUNT ON (B)(6) 2018 WITH 100MMH2O DUE TO SPINAL MENINGOCELE. ON UNKNOWN DATE, VENTRICULAR ENLARGEMENT WAS OBSERVED AND THE PATIENT HAD HEADACHE AND NAUSEA. AN OBSTRUCTION WAS SUSPECTED, THEREFORE, THE VALVE WAS REMOVED ON (B)(6) 2022 AND DRAINAGE WAS CARRIED OUT. THE PATIENT IS IN THE FOLLOW-UP.
Patient problems: Cerebral Ventriculomegaly; Headache; Nausea
MAUDE report 14398799 ↗InjuryApr 12, 2022Pressure Problem; Pressure Problem
A PHYSICIAN REPORTED THE SET PRESSURE OF A HAKIM VALVE (ID 823162) UNINTENTIONALLY CHANGED AFTER MRI EXAMINATION. THE VALVE WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2012 WITH SETTING 80MMH2O IN A (B)(6) YEAR-OLD MALE PATIENT. THE SET PRESSURE WAS NOT CHANGED SINCE IT WAS IMPLANTED. IT COULD NOT BE CHANGED BY USING NEODYMIUM. HOWEVER, THE PATIENT'S SYMPTOMS WORSENED SO THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.
Patient problems: Failure of Implant
MAUDE report 14084163 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page