CODMAN® HAKIM® 823148 (REF 82-3148)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10381780519225), received between Apr 5, 2022 and Jul 16, 2025 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED AN 18-YEAR-OLD MALE PATIENT WHO EXPERIENCED SHUNT MALFUNCTION AFTER PLACING CODMAN HAKIM PROGRAMMABLE VALVE (CHPV) (ID 823148) FOR PRIMARY HYDROCEPHALUS. THE PATIENT WHO HAD BEEN DIAGNOSED WITH PRIMARY HYDROCEPHALUS UNDERWENT SHUNT PLACEMENT FOR PRIMARY HYDROCEPHALUS WITH CODMAN HAKIM PROGRAMMABLE VALVE ON (B)(6) 2023, INITIALLY, THE PRESSURE WAS SET AT AROUND 90 MM OF H20. SUBSEQUENTLY, IT WAS INCREASED TO 120 MM OF H20, THROUGH SILVER PROGRAMMING BAG, BUT NOT CONFIRMED ON X-RAY, AND THEN FURTHER RAISED TO 140 MM OF H20 IN ORDER TO MANAGE OVER DRAINAGE, BUT WHILE CONFIRMING ON X-RAY THE PRESSURE WAS 90. AFTER A FEW HOURS, MEDICAL STAFF TRIED TO SET IT AT 110, AGAIN IT MOVED TO 70. AND THEN TO 50 AS CONFIRMED OVER X-RAY. THEY STOPPED EVERYTHING AND THE PATIENT WAS MOVED TO ICU (INTENSIVE CARE UNIT). THEY TRIED TO INCREASE THE PRESSURE TO 70 AND THE PRESSURE SEEN ON X-RAY WAS 30. THEY TRIED TO INCREASE THE PRESSURE TO 70, THE PRESSURE MOVED TO 50. AT THE TIME, OF REPORTING, THE OUTCOME OF THE EVENT SHUNT MALFUNCTION WAS UNKNOWN. PERTINENT LAB DATA INCLUDES ON AN UNSPECIFIED DATE, INVESTIGATION SHOWED THAT IT'S WORTH NOTING THAT THERE WERE NO FINDINGS SUGGESTIVE O

  Patient problems: Insufficient Information

  MAUDE report 22520229 ↗
• MalfunctionJul 15, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED MALFUNCTION OF A CODMAN HAKIM PROGRAMMABLE VALVE (CHPV) (ID 823148) DUE TO SECONDARY HYDROCEPHALUS. ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT SHUNT REVISION SURGERY 4 MONTHS BACK INITIAL PRESSURE WAS SET AROUND 100 MM OF H20, THE PATIENT HAD RAISED ICT AND IT WAS REPROGRAMMED TO 60MM OF H20 BUT DESIRED PRESSURE WAS NOT SET. THEY TRIED WITH DIFFERENT PROGRAMMER AND X-RAY WAS TAKEN FOR 8 TIMES AND THERE IS NO CHANGE IN THE PRESSURE INDICATOR AND SUSPECTING A SHUNT MALFUNCTION WAS UNABLE TO CHANGE PRESSURE OF UP SHUNT IT WAS STUCK AT 80, TRIED WITH 2 DIFFERENT MACHINES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT SHUNT MALFUNCTION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22506615 ↗
• InjuryJan 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  NA.

  Patient problems: Insufficient Information

  MAUDE report 21263326 ↗
• InjuryNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED WOUND INFECTION AND MISHANDLING OF HAKIM VALVE (ID 823148). NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 20613210 ↗
• MalfunctionSep 17, 2024Protective Measures Problem; Protective Measures Problem

  A FACILITY REPORTED A PATIENT OF UNSPECIFIED AGE AND GENDER WHO HAD SHUNT MALFUNCTION DURING THE USE OF CHPV SHUNT (CODMAN HAKIM PROGRAMMABLE VALVE ID 823148) AND SIPHONGUARD CSF CONTROL DEVICE FOR AN UNKNOWN INDICATION. THE ACTION TAKEN WITH CHPV SHUNT (CODMAN HAKIM PROGRAMMABLE VALVE) AND SIPHONGUARD CSF CONTROL DEVICE WAS UNKNOWN. REMARKS: THIS CASE WAS ASSESSED AS SERIOUS AS OTHER MEDICALLY IMPORTANT CONDITION. THIS CASE WAS VERIFIED BY PHYSICIAN. THIS IS A SERIOUS CASE REGARDING A PATIENT OF UNSPECIFIED AGE AND GENDER WHO HAD SHUNT MALFUNCTION DURING THE USE OF CHPV SHUNT (CODMAN HAKIM PROGRAMMABLE VALVE) AND SIPHONGUARD CSF CONTROL DEVICE FOR AN UNKNOWN INDICATION. THE CAUSALITY FOR THE EVENT IS CONSIDERED AS NOT ASSESSABLE BASED ON NATURE OF THE EVENT. HOWEVER, THERE IS LIMITED INFORMATION REGARDING PATIENT DEMOGRAPHICS, THERAPY DETAILS OF THE SUSPECT DRUG, ONSET DATE AND OUTCOME OF THE REPORTED EVENT, CONCOMITANT MEDICATION, RELEVANT MEDICAL HISTORY AND LAB DATA. AS PER THE COMPANY MANUAL OF BOTH THE SUSPECT DRUGS, THE REPORTED EVENT SHUNT MALFUNCTION IS LABELED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER SEVERAL ATTEMPTS; THEREFORE, PATIENT OUTCOME AND EVENT DETAILS

  Patient problems: Insufficient Information

  MAUDE report 20236932 ↗
• MalfunctionAug 22, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED A 60-YEAR-OLD FEMALE PATIENT WHO HAD SHUNT MALFUNCTION DURING THE USE OF CHPV STUNT (CODMAN HAKIM PROGRAMMABLE VALVE) (UNKNOWN ID) TO TREAT PRIMARY HYDROCEPHALUS. "CONCURRENT CONDITIONS WERE REPORTED AS BRAIN STEM GLIOMA AND PRIMARY HYDROCEPHALUS. NOT REPORTED: FAMILY HISTORY, PAST MEDICATION, CONCOMITANT MEDICATION AND CO-SUSPECT MEDICATION. " "ON (B)(6) 2024, THE PATIENT WAS ADMITTED IN HOSPITAL AND UNDERWENT CHPV STUNT PLACEMENT (CODMAN HAKIM PROGRAMMABLE VALVE). DURING SURGERY, THE SHUNT PRESSURE WAS NOT REPROGRAMMING CORRECTLY. IT WAS REPORTED THAT, THE TEAM ATTEMPTED TO ADJUST THE SHUNT PRESSURE WITH VARIOUS PROGRAMMERS UNDER MEDICAL SUPERVISION AND CONDUCTED AN MRI (MAGNETIC RESONANCE IMAGING), BUT THE SHUNT PRESSURE REMAINS STUCK." "THE PROGRAMMING WAS STUCK AT 80 MM H2O AND CANNOT BE INCREASED BEYOND THIS POINT. WHEN ATTEMPTING TO RESET THE PROGRAMMING TO 100 MM H2O, IT ONLY SETS TO 30 MM H2O. THE SAME ISSUE OCCURS WITH OTHER SETTINGS AS WELL. IT'S WORTH NOTING THAT THERE WERE NO FINDINGS SUGGESTIVE OF MENINGITIS, NO INDICATION OF HIGH PROTEIN COUNT, AND NO SIGNS OF AN INVERTED SHUNT. IT WAS REPORTED THAT, GIVEN THE INFORMATION GATHERED AND THE DISCUSSI

  Patient problems: Insufficient Information

  MAUDE report 20031140 ↗
• InjuryJul 26, 2024Obstruction of Flow; Obstruction of Flow

  A FACILITY REPORTED AN 8-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED SHUNT OCCLUSION, VOMITING, HEADACHE DURING THE USE OF HAKIM VALVE (ID UNKNOWN) FOR UNKNOWN INDICATION. NOT REPORTED: PATIENT MEDICAL HISTORY, CONCURRENT CONDITION, FAMILY HISTORY, PAST MEDICATION, CONCOMITANT AND CO-SUSPECT MEDICATIONS. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT IMPLANTATION OF A CODMAN HAKIM PROGRAMMABLE VALVE AT THE AGE OF 40 DAYS VIA UNKNOWN ROUTE. ON AN UNKNOWN DATE, PATIENT EXPERIENCED SHUNT BLOCK AND SHUNT FAILURE AND WAS REMOVED ON (B)(6) 2024, WITH EXTERNAL VENTRICULAR DRAINAGE (EVD) INSERTION. SHE WAS DOING GOOD WITH COMPLAINT OF VOMITING, HEADACHE. THE MAGNETIC RESONANCE IMAGING (MRI) SHOWED SHUNT FAILURE AND SHE HAD ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) BUT FAILED INDICATING SHUNT DEPENDENCY. LATER SHE UNDERWENT ¿PGM¿ SHUNT WHICH WAS FAILED. AT PRESENT SHE IS ON EVN PLANNING FOR REVISION OF ¿PGM¿ SHUNT SURGERY. THE OUTCOME OF THE EVENT WAS UNKNOWN AND MEDICAL INTERVENTION IS REQUIRED. THE ACTION TAKEN WITH HAKIM VALVE WAS UNKNOWN. THIS CASE WAS ASSESSED AS SERIOUS DUE TO OTHER MEDICALLY IMPORTANT CONDITION AND HOSPITALIZATION. THIS CASE WAS VERIFIED BY A PHYSICIAN. THE CAUSALITY FOR THE REP

  Patient problems: Headache; Vomiting

  MAUDE report 19838974 ↗
• InjuryJul 5, 2024Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 19680495 ↗
• MalfunctionJun 21, 2024Pressure Problem; Pressure Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 19589808 ↗
• InjuryDec 9, 2023Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 18298248 ↗
• InjuryMar 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2023. THE PATIENT WAS NO FEELING GOOD AND A CT SCAN WAS DONE. THERE WAS OVERDRAINAGE EVEN IN THE HIGHEST SETTING, THEREFORE THE VALVE WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 16592548 ↗
• InjuryDec 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A HAKIM VALVE (ID 823148) WAS IMPLANTED IN A 16 YEAR-OLD PATIENT VIA VP SHUNT ON (B)(6) 2022 WITH AN INITIAL SET PRESSURE OF 110 CROSSED CHECKED THROUGH X-RAY. ON (B)(6) 2022, PATIENT CAME BACK DETERIORATED WITH SYMPTOMS CEREBROSPINAL FLUID (CSF) OVER DRAINAGE (HEADACHE AND ALTERED SENSORIUM) AND PRESSURE WAS AUTOMATICALLY CHANGED TO 70. THE PHYSICIAN CHANGED THE PRESSURE TO 110 AND WAS DISCHARGED. ON (B)(6), THE PATIENT WAS ADMITTED AGAIN WITH DETERIORATION AND VALVE PRESSURE CHANGED AGAIN TO 70. THE VALVE WAS REMOVED AND REPLACED ON (B)(6), 2022. THE PATIENT CONDITION IMPROVED.

  Patient problems: Headache

  MAUDE report 15971897 ↗
• MalfunctionApr 12, 2022Fluid/Blood Leak; Device Difficult to Program or Calibrate; Fluid/Blood Leak; Device Difficult to Program or Calibrate

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823148) WAS IMPLANTED AND HAD PROGRAMMING DIFFICULTIES AND LEAKAGE. THE ISSUE WAS NOTED AFTER 10 DAYS FROM SURGERY WHILE THE PATIENT WAS ADMITTED WITH WORSENING SYMPTOMS. AT THE TIME OF THIS REPORT THE VALVE REMAINS IMPLANTED; HOWEVER, A REVISION SURGERY IS PLANNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14083999 ↗
• InjuryApr 5, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  A FACILITY REPORTED CONTINUOUS CSF OVER-DRAINAGE (200-300ML) EVEN AFTER CHANGING SEVERAL PRESSURE SETTINGS OF A HAKIM VALVE. THE PATIENT DEVELOPED SUBDURAL HEMATOMA; THEREFORE, THE VALVE WAS EXPLANTED ON (B)(6) 2022. THE VALVE WAS IMPLANTED TO TREAT SECONDARY HYDROCEPHALUS.

  Patient problems: Hematoma

  MAUDE report 14015871 ↗