CODMAN® HAKIM® 823832 (REF 82-3832)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 used with brain shunts to drain fluid and relieve pressure in hydrocephalus. The 39 reports mostly describe the valve not draining properly or becoming blocked, along with parts breaking and fluid or blood leaking from the system. Reports also mention swelling of the brain ventricles and hydrocephalus. There were no deaths, 34 injuries and 5 malfunctions, and 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
- 38
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10381780519805), received between Apr 19, 2022 and Feb 27, 2026 — classified as 33 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (12 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 Flow12
- Insufficient Device Problem Information4
- Break3
- Fluid/Blood Leak3
- Infusion or Flow Problem3
- Output Problem3
- Device Difficult to Program or Calibrate2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Cerebral Ventriculomegaly4
- Dizziness3
- Fever3
- Insufficient Information3
- Unspecified Infection3
- Coma2
- Hydrocephalus2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2026Insufficient Device Problem Information
MalfunctionJan 21, 2026Fluid/Blood Leak
InjuryJan 8, 2026Fracture
InjuryNov 10, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
A FACILITY REPORTED A PATIENT UNDERWENT A VENTRICULOPERITONEAL SHUNT (ID 823832) PROCEDURE ON (B)(6) 2025 AND WAS DISCHARGED WITHOUT COMPLICATIONS. SUBSEQUENT PRESSURE ADJUSTMENTS TO 180 SHOWED NO IMPROVEMENT IN VENTRICULAR SHRINKAGE ON COMPUTED TOMOGRAPHY (CT) SCANS. CURRENTLY, THE PATIENT IS STABLE BUT EXHIBITS SHORT-TERM MEMORY IMPAIRMENT. SINCE THE PRODUCT IS STILL IMPLANTED IN THE PATIENT, THE PHYSICIAN IS NOT SURE IF THE PROBLEM IS THE PRODUCT. HE SUSPECTED THAT THE VALVE COULD NOT BE ADJUSTED TO THE RIGHT PRESSURE, SINCE THE PATIENT CONTINUED TO BE OVER-DRAINAGE.
Patient problems: Memory Loss/Impairment
MAUDE report 23511330 ↗InjuryNov 7, 2025Infusion or Flow Problem; Infusion or Flow Problem
InjuryOct 31, 2025Restricted Flow rate; Restricted Flow rate
InjuryOct 31, 2025Obstruction of Flow; Obstruction of Flow
InjuryOct 2, 2025Output Problem; Output Problem
N/A.
Patient problems: Decreased Appetite; Partial Hearing Loss; Speech Disorder
MAUDE report 23199752 ↗InjuryJul 31, 2025Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2025, THE PATIENT DEVELOPED SYMPTOMS OF NAUSEA AND DISCOMFORT. MULTIPLE PRESSURE ADJUSTMENTS WERE ATTEMPTED BUT FAILED TO ALLEVIATE THE SYMPTOMS, LEADING TO A SUSPECTED BLOCKAGE. AS A RESULT, THE ORIGINAL SHUNT WAS REMOVED AND REPLACED WITH THE SAME MODEL ON (B)(6) 2025.
Patient problems: Nausea
MAUDE report 22677253 ↗InjuryJul 25, 2025Obstruction of Flow; Obstruction of Flow
InjuryJul 16, 2025Output Problem; Output Problem
InjuryJun 18, 2025Improper Flow or Infusion; Improper Flow or Infusion
A FACILITY REPORTED A HAKIM VALVE (ID: 823832) WAS IMPLANTED ON (B)(6) 2025, VIA VENTRICULOPERITONEAL (VP) SHUNT. THERE WAS NO IMPROVEMENT IN VENTRICULAR SIZE POSTOPERATIVELY, WITH ACCOMPANYING MYDRIASIS (PUPIL DILATION). ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED TO REPLACE THE SHUNT WITH AN ALTERNATIVE BRAND. POSTOPERATIVE IMAGING SHOWED NORMALIZED VENTRICLES, THOUGH THE PATIENT REMAINED COMATOSE. AN EVALUATION OF THE EXPLANTED DEVICE REVEALED ABNORMALLY SLOW FLOW RATE AT THE SHUNT VALVE OUTLET. THE PATIENT BECAME COMATOSE ON (B)(6) 2025; HOWEVER, ACCORDING TO INFORMATION PROVIDED, IT IS UNDETERMINED IF THE PATIENT COMATOSE STATE IS DUE TO VALVE FAILURE.
Patient problems: Coma
MAUDE report 22283719 ↗InjuryMay 28, 2025Obstruction of Flow; Obstruction of Flow
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: EVENT REPORTED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2022 DUE TO SUBARACHNOID HEMORRHAGE. THE PATIENT UNDERWENT CLIPPING OF THE LEFT MIDDLE CEREBRAL ARTERY, FOLLOWED BY HYDROCEPHALUS. ON (B)(6) 2024, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED POST-OPERATIVE CHANGES CONSISTENT WITH A VENTRICULOPERITONEAL SHUNT, WITH POOR DRAINAGE AT THE PROXIMAL CATHETER, SUGGESTING POSSIBLE CATHETER OBSTRUCTION. THE PATIENT'S FAMILY WAS INSTRUCTED TO PERFORM MANUAL COMPRESSION 100-200 TIMES DAILY AS CONSERVATIVE MANAGEMENT, AND RECOVERY HAS BEEN SMOOTH. CURRENTLY, THE PATIENT IS IN STABLE CONDITION WITH NO COMPLICATIONS. THE DEVICE IS STILL IMPLANTED.
Patient problems: Hydrocephalus
MAUDE report 22096892 ↗InjuryMay 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00107. A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE WERE IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD FEVER AND WAS TESTED WITH CSF (CEREBRO-SPINAL FLUID) POSITIVE. THE PATIENT RECEIVED ANTI-INFECTIVE THERAPY. ON (B)(6) 2025, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND IMPLANTED A NEW HAKIM VALVE (ID 823832) AND A NEW BACTISEAL CATHETER (ID 823072). THE PATIENT IS STABLE.
Patient problems: Fever; Unspecified Infection
MAUDE report 22017976 ↗InjuryMay 1, 2025Obstruction of Flow; Obstruction of Flow
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00090. A FACILITY REPORTED A HAKIM VALVE (ID: 823832) AND BACTISEAL CATHETER (ID: 823072) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT OPERATION ON (B)(6) 2025. THE POSTOPERATIVE CONDITION IS GOOD. THE PATIENT WAS DIAGNOSED WITH SECONDARY HYDROCEPHALUS, HISTORY OF BRAIN TUMOR RESECTION AND PROSTHETIC EYE. COMPUTED TOMOGRAPHY (CT) REEXAMINATION ON (B)(6) REVEALED HYDROCEPHALUS: A SMALL AMOUNT OF BLOOD MAY BE ACCUMULATED IN THE KNEE OF THE CORPUS CALLOSUM. ON (B)(6), THE PATIENT DEVELOPED LOW FEVER, AND REEXAMINATION CT REVEALED A SMALL AMOUNT OF HEMATOSIS IN THE KNEE OF THE CORPUS CALLOSUM. ON (B)(6), THE PATIENT HAD SMALL STRIDES AND SLOW MOVEMENT, AND THEN THE SHUNT PRESSURE WAS ADJUSTED FROM 160MM WATER COLUMN TO 140MM WATER COLUMN. IN THE EVENING, THE PATIENT DEVELOPED CONFUSION OF CONSCIOUSNESS, AND REEXAMINATION CT SHOWED DELAYED BLEEDING AT THE RIGHT FRONTAL PUNCTURE SITE, WHICH WAS LARGER THAN BEFORE, PERIPHERAL EDEMA, PRESSURE ON THE FRONTAL CORNER OF THE RIGHT LATERAL VENTRICLE, AND A THIN SUBDURAL HEMATOMA IN THE RIGHT FRONTOTEMPORAL AREA, WITH THE MIDLINE STRUCTURE SHIFTING SLIGHTLY TO THE LEFT. CT
Patient problems: Confusion/ Disorientation; Fever; Hydrocephalus
MAUDE report 21944068 ↗InjuryApr 23, 2025Obstruction of Flow; Obstruction of Flow
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00083, 3013886523-2025-00084. A FACILITY REPORTED A HAKIM VALVE (ID 823832), A BACTISEAL VENTRICULAR CATHETER (ID 823073), AND A BACTISEAL PERITONEAL CATHETER (ID 823074) WERE IMPLANTED ON (B)(6) 2025. AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUBCUTANEOUS HYDROPS. THEREFORE, THE PRODUCTS WERE REMOVED AND REPLACED DUE TO SUSPICION OF OCCLUSION. THE PATIENT IS STABLE.
Patient problems: Cyst(s)
MAUDE report 21893866 ↗InjuryApr 4, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2025. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) CHECK ON (B)(6) 2025, AND THE VALVE WAS AT THE PROPER POSITION. ON (B)(6) 2025, THE PATIENT WAS FOUND WITH UNDERDRAINAGE AND THE VENTRICLE WAS ENLARGED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED. THE PATIENT IS STABLE.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 21773362 ↗InjuryMar 28, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A FACILITY REPORTED A HAKIM VALVE (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2025. AFTER THE PROCEDURE, THERE WAS NO IMPROVEMENT IN THE PATIENT'S VENTRICLE, IT DID NOT SHRINK. ON (B)(6) 2025, THE PHYSICIAN ADJUSTED THE VALVE PRESSURE TO 140 MMHG, BUT THE VENTRICLE SHOWED NO CHANGE. AN X-RAY ON (B)(6) 2025 REVEALED THAT THE VALVE WAS UNABLE TO BE PROGRAMMED TO THE SET PRESSURE. ON (B)(6) 2025, THE PHYSICIAN REMOVED AND REPLACED THE VALVE WITH A NEW DEVICE. AFTER THE REVISION PROCEDURE, THE PATIENT HAD AN X-RAY CHECK, AND THE VALVE HAS BEEN PROGRAMMED TO THE SETTING PRESSURE. NO INFORMATION IS AVAILABLE IF THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS. THE PATIENT IS STABLE.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 21721030 ↗InjuryFeb 27, 2025Break; Break
InjuryJan 3, 2025Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2024. ON (B)(6), THE PHYSICIAN FOUND THAT THE CEREBRAL VENTRICLE DID NOT SHRINK WHEN ADJUSTING THE SETTING PRESSURE. IN DECEMBER, THE PHYSICIAN SUSPECTED THE VALVE WAS OCCLUDED AND CONNECTED THE PERITONEAL CATHETER TO AN EXTERNAL DRAINAGE TUBE. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS WAITING FOR REVISION SURGERY TO REPLACE THE VALVE. ACCORDING TO ADDITIONAL INFORMATION, THE REVISION DATE IS UNKNOWN AND THE PATIENT EXPERIENCED DIZZINESS BECAUSE THE VALVE DID NOT DRAIN THE CEREBROSPINAL FLUID (CSF).
Patient problems: Dizziness
MAUDE report 21070598 ↗InjuryAug 27, 2024Unintended System Motion; Unintended System Motion
A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2024 WITH SETTING 140, BUT IT WAS STUCK AT 30 (AFTER X-RAY CHECK). THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THE PATIENT RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20080659 ↗MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
InjuryMay 9, 2024Pressure Problem; Pressure Problem
A FACILITY REPORTED A HAKIM VALVE (ID (B)(4) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2023, DUE TO HIGH ICP OF 350MM/H2O AND VENTRICULOMEGALY. AFTER THE PROCEDURE THE PATIENT WAS NOT FEELING WELL. THEREFORE, THE PHYSICIAN ADJUSTED THE PRESSURE TO 200MM/H2O AND THE PATIENT WAS DISCHARGED. THE PRESSURE SETTING RECORDED ON (B)(6) 2023, WAS 110MM/H2O AFTER AN X-RAY WAS TAKEN, HOWEVER, ON THE FOLLOWING DAY, (B)(6) 2023, THE PATIENT'S LUMBAR PUNCTURE PRESSURE WAS 60MM/H2O ONLY. THE VALVE PRESSURE WAS READJUSTED TO 180 MM/H20 UNDER X-RAY ON (B)(6) 2024. THE PATIENT WAS NOT WILLING TO HAVE AN X-RAY RECHECK DESPITE THE UNCLEAR RESULT ON THE X-RAY. THE PATIENT RECEIVED A TRANSFUSION FOR A WEEK AND THE LUMBAR PUNCTURE PRESSURE OF PATIENT REMAINED 60MM/H2O. THE PATIENT HAD A LUMBAR PUNCTURE PRESSURE OF 0MM/H2O ON (B)(6) 2023. THE PATIENT EXPERIENCED A HEADACHE DUE TO A VALVE ISSUE.
Patient problems: Headache
MAUDE report 19282313 ↗InjuryMay 6, 2024Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
A FACILITY REPORTED THAT A HAKIM VALVE/PROG VALVE INLINE W SG ((B)(6)) WAS IMPLANTED ON (B)(6) 2023. SEVERAL MONTHS LATER, THE PHYSICIAN FOUND THAT THE VALVE COULD NOT BE PROGRAMMED. ON MARCH 9, 2024, THE PHYSICIAN PERFORMED A REVISION PROCEDURE AND DISCOVERED THAT NO CEREBROSPINAL FLUID (CSF) WAS FLOWING OUT OF THE ABDOMINAL CATHETER AND SUSPECTED THAT THE VALVE WAS BLOCKED. THE PHYSICIAN RETRIEVED THE VALVE AND REPLACED IT WITH A NEW HAKIM VALVE (823832). IT WAS REPORTED THAT THE PATIENT¿S CURRENT STATUS IS STABLE. THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19247495 ↗MalfunctionApr 5, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED A HAKIM VALVE (ID (B)(6)) WAS LEAKING CEREBROSPINAL FLUID. THE EVENT OCCURRED DURING THE PROCEDURE BEFORE IMPLANTATION SITE CLOSURE. THE EVENT DID NOT LED TO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19054347 ↗
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- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.