CODMAN HAKIM SIPHONGUARD 82-3842Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve In-Line Valve with SIPHONGUARD Device and Unitized Distal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Programmable Valve, 14cm Ventricular Catheter, 120cm Peritoneal Catheter, Information Manual, Right Angle Adapter 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
- 15
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886704041856), received between Feb 2, 2022 and Jan 21, 2026 — classified as 14 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (6 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
- Obstruction of Flow6
- Pressure Problem3
- Adverse Event Without Identified Device or Use Problem2
- Infusion or Flow Problem1
- Insufficient Device Problem Information1
- Output Problem1
- Separation Problem1
Patient problems
- Insufficient Information6
- Cerebral Ventriculomegaly5
- Hydrocephalus2
- No Clinical Signs, Symptoms or Conditions2
- Ambulation or Postural Difficulties1
- Confusion/ Disorientation1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Obstruction of Flow
InjuryJan 2, 2026Insufficient Device Problem Information
InjuryDec 27, 2024Output Problem; Output Problem
InjuryMay 30, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823842) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE AND SETTING DUE TO UNKNOWN REASON. THE VALVE WAS REMOVED DUE TO AN OBSTRUCTION ON AN UNKNOWN DATE. AFTER CHECKING THE VALVE, IT WAS FOUND THAT THE PROXIMAL SIDE OF THE CONNECTOR WAS DAMAGED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE DEVICE WAS REPLACED AND WHAT TYPE OF DAMAGE WAS FOUND. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OBSTRUCTION.
Patient problems: Insufficient Information
MAUDE report 19430630 ↗InjurySep 13, 2023Separation Problem; Separation Problem
A PHYSICIAN REPORTED A BACTISEAL PERITONEAL CATHETER (ID 823074) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON AN UNKNOWN DATE. THE CATHETER WAS DETACHED, THEREFORE IT WAS REMOVED AND REPLACED ON AN UNKNOWN DATE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE.
Patient problems: Insufficient Information
MAUDE report 17738086 ↗InjuryMay 16, 2023Pressure Problem; Pressure Problem
InjuryApr 25, 2023Obstruction of Flow; Obstruction of Flow
InjuryJan 4, 2023Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823842) WAS IMPLANTED DUE TO INPH (IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS) VIA VENTRICULAR PERITONEAL (VP) SHUNT ON (B)(6) 2021 WITH UNKNOWN SETTING. THE 82 YEAR-OLD FEMALE PATIENT HAD GAIT DISTURBANCE AND VENTRICULAR ENLARGEMENT DURING THE OUTPATIENT FOLLOW UP IN (B)(6) 2022. DUE TO SUSPICION OF OBSTRUCTION BY SHUNT ANGIOGRAPHY, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Ambulation or Postural Difficulties; Cerebral Ventriculomegaly
MAUDE report 16095483 ↗InjuryJun 8, 2022Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823842) WAS IMPLANTED VIA UNKNOWN-SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. DUE TO UNDERDRAINAGE 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 UNDERDRAINAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14633122 ↗InjuryJun 1, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823842) WAS IMPLANTED IN THE PATIENT VIA V-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. VALVE OBSTRUCTION WAS SUSPECTED, AND ON (B)(6) 2022, THE VALVE WAS REMOVED AND REPLACED. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OBSTRUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14566477 ↗MalfunctionApr 20, 2022Pressure Problem; Pressure Problem
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00157. A PHYSICIAN REPORTED TWO HAKIM VALVES WERE IMPLANTED IN A (B)(6) YEAR-OLD FEMALE PATIENT VIA V-P SHUNT IN 2020 WITH UNKNOWN SETTING. BOTH VALVES WERE IMPLANTED AT THE SAME TIME. ON (B)(6) 2022, THE SET PRESSURE OF THE VALVES COULD NOT BE CHANGED, AND X-RAY EXAMINATION CONFIRMED VENTRICULAR ENLARGEMENT. A CEREBROSPINAL FLUID DRAINAGE IS BEING PERFORMED. IN HE FIRST WEEK OF APRIL A REVISION SURGERY WAS PERFORMED, ONE VALVE WAS REPLACED AND THE PATIENT RECOVERED. THE OTHER VALVE HAS A POOR CHANGE IN THE SET PRESSURE, BUT SINCE NO OBSTRUCTION HAS BEEN CONFIRMED, IT REMAINS IMPLANTED.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 14159779 ↗InjuryApr 20, 2022Pressure Problem; Pressure Problem
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT : 3013886523-2022-00170. A PHYSICIAN REPORTED TWO HAKIM VALVES WERE IMPLANTED IN A (B)(6) YEAR-OLD FEMALE PATIENT VIA V-P SHUNT IN 2020 WITH UNKNOWN SETTING. BOTH VALVES WERE IMPLANTED AT THE SAME TIME. ON (B)(6) 2022, THE SET PRESSURE OF THE VALVES COULD NOT BE CHANGED, AND X-RAY EXAMINATION CONFIRMED VENTRICULAR ENLARGEMENT. A CEREBROSPINAL FLUID DRAINAGE IS BEING PERFORMED. IN HE FIRST WEEK OF APRIL A REVISION SURGERY WAS PERFORMED, ONE VALVE WAS REPLACED AND THE PATIENT RECOVERED. THE OTHER VALVE HAS A POOR CHANGE IN THE SET PRESSURE, BUT SINCE NO OBSTRUCTION HAS BEEN CONFIRMED, IT REMAINS IMPLANTED.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 14159776 ↗InjuryMar 10, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED VIA L-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. VALVE OBSTRUCTION WAS SUSPECTED AND WAS REMOVED AND REPLACED IN (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13722219 ↗InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED A CERTAS VALVE (UNKNOWN ID) WAS IMPLANTED IN A (B)(6) FEMALE VIA L-P SHUNT ON (B)(6) 2019 WITH UNKNOWN SETTING. DUE TO SHUNT FAILURE, A HAKIM V-P SHUNT (ID 823842) WAS ADDED ON (B)(6) 2021. THE V-P SHUNT PRESSURE WAS REDUCED TO 30 MMH2O AND THE PATIENT WAS IN THE FOLLOW UP. A YEAR LATER, HYDROCEPHALUS WAS CONFIRMED BY CT AND ON (B)(6) 2022, THE HAKIM VALVE (ID 823842) WAS REMOVED AND REPLACED.
Patient problems: Hydrocephalus
MAUDE report 13543403 ↗InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED IN A (B)(6) FEMALE PATIENT VIA V-P SHUNT IN (B)(6) 2016 WITH UNKNOWN SETTING. SINCE THE VALVE WAS IMPLANTED THE PATIENT'S VENTRICLE HAD A SLIT-LIKE SHAPE, AND THE PROGRESS WAS OBSERVED IN A RELATIVELY HIGH-PRESSURE RANGE. THIS PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF ACUTE HYDROCEPHALUS ON (B)(6) 2021. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2021. NO INFORMATION ABOUT VALVE FAILURE IS AVAILABLE.
Patient problems: Hydrocephalus
MAUDE report 13428437 ↗
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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.
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