CODMAN® HAKIM® 823162 (REF 82-3162)Recalls & reported problems
Integra Lifesciences Production Corporation · 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) · Class 2 · Implant
Quick summary
This Codman Hakim programmable in-line valve is implanted to drain fluid from the brain, and its setting can be adjusted in steps. The 28 adverse event reports mostly describe the valve not draining properly or becoming blocked, so fluid builds up again and the valve sometimes has to be removed and replaced; reports also mention the valve cracking or breaking and trouble adjusting its setting. There were no deaths and 27 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10381780519232), received between Jan 6, 2022 and Feb 6, 2026 — classified as 26 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (16 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow16
- Break3
- Infusion or Flow Problem3
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Program or Calibrate1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Insufficient Flow or Under Infusion1
Patient problems
- Insufficient Information14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Headache2
- Hydrocephalus2
- Cerebral Ventriculomegaly1
- Cerebrospinal Fluid Leakage1
- Dizziness1
- Fever1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Break
InjurySep 26, 2025Obstruction of Flow; Obstruction of Flow
InjuryJun 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJan 3, 2025Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED ON (B)(6) 2024. TWO WEEKS AFTER THE PROCEDURE, THE HYDROCEPHALUS OF THE PATIENT DIDN'T IMPROVE AND THE PHYSICIAN SUSPECTED THAT THE VALVE WAS BLOCKED. THEREFORE, ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A PROCEDURE TO RETRIEVE THE VALVE.
Patient problems: Insufficient Information
MAUDE report 21067491 ↗InjuryOct 17, 2024Break; Break
InjuryOct 17, 2024Break; Break
MalfunctionOct 4, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A FACILITY REPORTED A HAKIM VALVE (ID (B)(4) WAS IMPLANTED ON (B)(6) 2024. DURING IMPLANTATION PROCEDURE, THE VALVE WAS NOT DRAINING CEREBROSPINAL FLUID (UNDERDRAINAGE); THEREFORE, IT WAS REMOVED AND REPLACED WITH A COMPETITORS VALVE. THE INTEGRA CATHETERS REMAINED IMPLANTED AND CONNECTED WITH COMPETITORS VALVE. THE EVENT LED TO MORE THAN 30 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368863 ↗InjuryJun 26, 2024Obstruction of Flow; Obstruction of Flow
InjuryJun 26, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT, ON UNKNOWN DATE WITH UNKNOWN SETTING DUE TO CONGENITAL HYDROCEPHALUS AND MYELOMENINGOCELE. DUE TO SUSPICION OF OBSTRUCTION, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OBSTRUCTION. IT IS ALSO UNKNOWN HOW THE VALVE OBSTRUCTION WAS DISCOVERED.
Patient problems: Insufficient Information
MAUDE report 19620994 ↗InjuryJun 8, 2024Obstruction of Flow; Obstruction of Flow
THE PHYSICIAN REPORTED A HAKIM VALVE (ID (B)(6)) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT DUE TO CONGENITAL HYDROCEPHALUS ON AN UNKNOWN DATE WITH UNKNOWN SETTING. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED TO REMOVE THE VALVE DUE TO OBSTRUCTION. THE PATIENT'S PRIMARY DISEASE IS MYELOMENINGOCELE. THE PATIENT IS UNDER FOLLOW-UP. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OBSTRUCTION. IT IS ALSO UNKNOWN HOW THE OBSTRUCTION WAS DISCOVERED AND IF THE VALVE WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 19493954 ↗InjuryJun 7, 2024Obstruction of Flow; Obstruction of Flow
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2024-00132. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. DUE TO SUSPICION OF OBSTRUCTION, A REVISION SURGERY WAS PERFORMED. THE VALVE WAS REMOVED AND REPLACED WITH ID 823162 AND A DIFFERENT LOT NUMBER ON APRIL 26, 2024. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO SUSPECTED OBSTRUCTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19487694 ↗InjuryApr 22, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A FACILITY REPORTED A HAKIM VALVE (ID (B)(6)) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULAR PERITONEAL (VP) SHUNT WITH UNKNOWN SETTING IN 2018. ON (B)(6) 2024, WHEN ATTEMPTING TO CHANGE THE SETTING, IT COULD NOT BE CHANGED EVEN UNDER FLUOROSCOPIC GUIDANCE. THEREFORE, A REVISION SURGERY WAS PERFORMED. THE VALVE WAS REPLACED WITH A CERTAS VALVE (UNKNOWN PRODUCT ID). THE PATIENT'S PRIMARY DISEASE WAS SPINA BIFIDA. THE PATIENT IS CURRENTLY IN FOLLOW- UP. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO VALVE ISSUE.
Patient problems: Insufficient Information
MAUDE report 19160788 ↗InjuryMar 24, 2024Material Integrity Problem; Material Integrity Problem
A PHYSICIAN REPORTED A HAKIM VALVE (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2024 WITH SETTING 190MMH20 AND THE PROCEDURE PERFORMED WAS VENTRICULAR PLEURAL SHUNT. THE PATIENT EXPERIENCED ISSUES WITH OVERDRAINAGE TO UNDERDRAINAGE AND COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED IT. THE PATIENT EXPERIENCED HEADACHES AND LETHARGIC NEUROLOGIC CHANGES. THE VALVE WAS SEVERED FROM SIPHONGUARD. THEREFORE, IT WAS REMOVED ON (B)(6) 2024 AND PLACED WITH EXTERNAL VENTRICULAR DRAINAGE (EVD).
Patient problems: Headache; Lethargy
MAUDE report 18966532 ↗InjuryMar 24, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) PLACED ON (B)(6) 2024 WAS NOT FLOWING, THEREFORE IT WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 18966524 ↗InjuryFeb 20, 2024Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (B)(6) WAS IMPLANTED IN A FEMALE PATIENT DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULOATRIAL SHUNT ON (B)(6) 2023, WITH A SET PRESSURE OF 160MMH²O. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN LATE JANUARY. DURING THE OUTPATIENT VISIT IN EARLY FEBRUARY, IT WAS CONFIRMED THAT HYDROCEPHALUS WAS PROGRESSING AND CEREBROSPINAL FLUID (CSF) WAS LEAKING FROM SURGICAL WOUND. AN ATTEMPT WAS MADE TO CHANGE THE PRESSURE OF THE VALVE USING A HIGH POWER MAGNET HOWEVER, THE HAKIM PROGRAMMER FAILED. THERE WAS A SUSPICION OF OBSTRUCTION THEREFORE, THE VALVE, PERITONEAL CATHETER, AND VENTRICULAR CATHETER WERE REMOVED ON (B)(6) 2024. WHEN EXTRACTING, THE SURGEON NOTICED THE DAMAGE IN SILICONE HOUSING OF THE VALVE. THE PATIENT IS ON EXTERNAL DRAINAGE. SHE HAD FEVER WITH ANTIBIOTIC TREATMENT. THE PATIENT IS ON FOLLOW-UP AND V-A SHUNT WILL BE PERFORMED AFTER 2 TO 3 WEEKS.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 18743588 ↗InjuryJan 25, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED VIA VENTRICULOPERITONEAL SHUNT ON JANUARY 10, 2024 WITH A SET PRESSURE OF 70MMH2O. IT WAS CONFIRMED THAT THE CEREBROSPINAL FLUID WAS NOT FLOWING DUE TO OBSTRUCTION; THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON JANUARY 10, 2024 WITH A SET PRESSURE OF 20MMH20 . ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OBSTRUCTION.
Patient problems: Insufficient Information
MAUDE report 18584255 ↗InjuryJan 9, 2024Obstruction of Flow; Obstruction of Flow
InjuryJun 27, 2023Obstruction of Flow; Obstruction of Flow
InjuryOct 25, 2022Obstruction of Flow; Obstruction of Flow
THIS IS 2 OF 2 REPORTS (SAME VALVE, DIFFERENT EVENTS) LINKED TO MFG REPORT NUMBER: 3013886523-2022-00484. A PHYSICIAN REPORTED A HALIM VALVE (ID 823842) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. ON (B)(6) 2022 A SURGERY WAS PERFORMED TO CORRECT THE POSITION OF THE PERITONEAL CATHETER. EXTERNAL DRAINAGE WAS PERFORMED VIA A VALVE ON (B)(6) 2022 DUE TO INFECTION. THE VALVE WAS OBSTRUCTED AND THE CEREBROSPINAL FLUID COULD NOT BE DISCHARGED; THEREFORE, THE VALVE WAS REMOVED, ONLY THE RESERVOIR WAS REPLACED. ACCORDING TO REPORTER IT IS UNKNOWN IF THE INFECTION WAS RELATED TO THE VALVE. THIS REPORT IS FOR THE VALVE OBSTRUCTION.
Patient problems: Unspecified Infection
MAUDE report 15668358 ↗InjurySep 14, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED IN A 2 MONTH OLD PATIENT VIA UNKNOWN SHUNT AND DATE. ON (B)(6) 2022, THE PATIENT HAD A SUBCUTANEOUS RETENTION, LARGE FONTANEL SWELLING, FEVER, AND VOMITING. ON (B)(6) 2022, SHUNT IMAGING WAS PERFORMED AND OBSTRUCTION WAS CONFIRMED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. THE PATIENT IS IN FOLLOW UP.
Patient problems: Fever; Vomiting
MAUDE report 15419402 ↗InjuryApr 12, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED IN A (B)(6) MALE PATIENT VIA V-P SHUNT ON (B)(6) 2022 WITH SETTING 80MMH2O. VENTRICULAR ENLARGEMENT WAS OBSERVED EVEN WHEN THE SET PRESSURE WAS LOWERED. VALVE OBSTRUCTION WAS SUSPECTED; THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 14084165 ↗InjuryMar 29, 2022Obstruction of Flow; Obstruction of Flow
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00121 . A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A (B)(6) FEMALE PATIENT VIA V-P SHUNT ON (B)(6), 2020 WITH SETTING 4. ON AN UNKNOWN DATE, THE PRESSURE WAS SET TO SETTING 8. ON (B)(6), 2021, THE HAKIM VALVE WAS ADDED BY CONNECTING IT WITH A Y-SHAPED CONNECTOR. THE SETTING HAS NOT BEEN CHANGED SINCE THE INITIAL PRESSURE OF 30MMH2O. SUBCUTANEOUS RETENTION OCCURRED AND VALVE OBSTRUCTION WAS SUSPECTED, THE VALVES WERE REMOVED AND REPLACED ON (B)(6), 2022.
Patient problems: Insufficient Information
MAUDE report 13942964 ↗InjuryMar 24, 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) MALE PATIENT VIA V-P SHUNT ON (B)(6) 2021 WITH 80 MMH2O. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). THE PATIENT WAS STILL ILL AFTER THE VALVE WAS PLACED AND THE PATIENT'S CONDITION DID NOT CHANGE EVEN WHEN THE SETTING WAS LOWERED TO 60MMH2O. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 13871733 ↗InjuryMar 8, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED IN A FEMALE PATIENT VIA V-P SHUNT ON (B)(6) 2021 WITH 100MMH2O. AFTER THAT, THE PATIENT HAD BEEN FOLLOWED UP. OBSTRUCTION AND ACUTE HYDROCEPHALUS WAS SUSPECTED; THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6), 2022 TO REMOVE AND REPLACE THE VALVE. PRIMARY DISEASE - MENINGOCELE.
Patient problems: Hydrocephalus
MAUDE report 13697143 ↗InjuryJan 6, 2022Infusion or Flow Problem; Infusion or Flow Problem
THIS IS 3 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2021-00580, 3013886523-2021-00581, 3013886523-2021-00583. IT WAS REPORTED FOUR PATIENTS WERE IMPLANTED WITH HAKIM VALVE (ID 823162) AND DEVELOPED HYDROMAS (OVERDRAIN). THE VALVES WERE SET AT 120MMH2O AND THEN ADJUSTED TO THE HIGHER SETTING (140MMH2O) TO RESOLVE THE HYDROMA. PATIENTS SYMPTOMS WERE RESOLVED AFTER THE PROGRAMMING RESET.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13174566 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.