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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10381780534563), received between May 8, 2024 and Aug 4, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• OtherAug 4, 2026Improper Flow or Infusion

  Patient problems: Dizziness; Headache

  MAUDE report 50131234 ↗
• InjuryMar 30, 2026No Flow

  A FACILITY REPORTED A HAKIM VALVE (ID 823148) WAS IMPLANTED ON (B)(6) 2025, WITH INITIAL PRESSURE FIXED AT 120MMH2O. THE PHYSICIAN TRIED TO ADJUST THE PRESSURE PERIODICALLY, HOWEVER, THEY FOUND MISMATCH AGAINST THE SET PRESSURE. THE PATIENT EXPERIENCED A DECLINE IN SENSORIUM, AND IMAGING SHOWED VENTRICULAR DILATATION DESPITE THE SHUNT TUBING BEING IN SITU. THE PATIENT WAS ADMITTED, THE SHUNT ADJUSTED TO 40MMH2O, EVEN THOUGH ICP WASN'T SETTLED, AND ADJUSTED, THE CSF DRAINAGE WASN'T FLOWING THROUGH SHUNT, THEREFORE IT WAS REMOVED ON (B)(6) 2026.

  Patient problems: Cerebral Ventriculomegaly; Confusion/ Disorientation

  MAUDE report 24711782 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED: "A 75 YEAR-OLD PATIENT HAD A TRAFFIC ACCIDENT ON (B)(6) 2025, WITH HEAD INJURY AND RIGHT FRONTO-TEMPORO-PARIETAL SDH (SUBDURAL HEMATOMA) WITH MASS EFFECT, LEFT FRONTO-PARIETAL ATYPICAL CONTUSION, LEFT TEMPORAL MINIMAL SAH (SUBARACHNOID HEMORRHAGE), MINIMAL BRAINSTEM CONTUSION, RIGHT FRONTAL SINUS AND NASAL BONE FRACTURE, RIGHT ORBITAL WALL DISPLACED FRACTED, RIGHT 3RD TO 6TH RIB FRACTURE, SEPTIC SHOCK WITH RIGHT SIDED PNEUMONIA, S/P RIGHT FTP DECOMPRESSIVE CRANIOTOMY ON (B)(6) 2025 OUTSIDE, S/P PEG TUBE INSERTION - (B)(6) 2025, SUNKEN FLAP SYNDROME, S/P RIGHT FTP 3D TITANIUM MESH CRANIOPLASTY DONE ON (B)(6) 2025, UROSEPSIS WITH SEPTIC SHOCK, STATUS EPILEPTICUS, PARALYTIC ILEUM. CONCURRENT CONDITIONS WERE REPORTED AS: DIABETES MELLITUS, HYPERTENSION. NO FAMILY HISTORY WAS REPORTED. PAST MEDICATION WAS NOT REPORTED. CONCOMITANT MEDICATION AND COSUSPECT MEDICATIONS WERE NOT REPORTED." "ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH A CODMAN HAKIM PROGRAMMABLE VALVE VIA UNKNOWN ROUTE." "ON AN UNSPECIFIED DATE, THE PATIENT PRESENTED WITH EPISODE OF LEFT UPPER LIMB AND LOWER LIMB JERKY MOVEMENT ABOUT AN HOUR, ASSOCIATED WITH UP ROLLING OF EYEBALL AND INCREASED BLOOD PRES

  Patient problems: Convulsion/Seizure; Sleepiness/Drowsiness/Somnolence

  MAUDE report 24532783 ↗
• InjuryOct 2, 2025Collapse; Collapse

  "A PHYSICIAN REPORTED A PATIENT UNDERWENT PLACEMENT OF CODMAN HAKIM PROGRAMMABLE SHUNT ON (B)(6) 2025, PATIENT RECOVERED WELL, PATIENT WAS UNDER REGULAR FOLLOW UP, LAST FOLLOW UP IN OPD (OUTPATIENT DEPARTMENT) WAS ON (B)(6) 2025. ON (B)(6) 2025, AGAIN HE WAS RE-ADMITTED WITH COMPLAINTS OF RECURRENT VOMITING AND DULLNESS (MENTAL IMPAIRMENT). NON-CONTRAST COMPUTED TOMOGRAPHY OF THE HEAD WAS DONE THAT SHOWED SHUNT IN PLACE. SHUNT CHAMBER HAD POOR REFILL, SHUNT PRESSURE WAS DECREASED FROM 130 TO 110 ON (B)(6) 2025, EVEN AFTER LOWERING THE PRESSURE VOMITING DID NOT STOP AND PATIENT BECAME MORE DULL, SO PATIENT WAS PLANNED FOR SHUNT REVISION ON (B)(6) 2025. ON OPENING THE SKIN FLAP A RENT WAS NOTED IN CSF (CEREBROSPINAL FLUID) CHAMBER OF SHUNT FROM WHERE CSF WAS OOZING, FOUND RESERVOIR IS COLLAPSED SUSPECTING HARDWARE MALFUNCTION (NO CONFIRMATIVE X-RAYS TAKEN), SO DECISION WAS MADE TO CHANGE WHOLE SHUNT ASSEMBLY."

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem; Vomiting

  MAUDE report 23199755 ↗
• InjuryAug 22, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A PHYSICIAN REPORTED A 76-YEAR-OLD ELDERLY FEMALE PATIENT HAD A HAKIM VALVE MALFUNCTION (ID 823148). THE VALVE WAS IMPLANTED DUE TO NORMAL PRESSURE HYDROCEPHALUS (NPH). "ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH THE CHPV SHUNT (CODMAN HAKIM PROGRAMMABLE VALVE) MEDICAL DEVICE. THE LOT/BATCH NUMBER WAS 7356563 AND EXPIRY DATE WAS 31-MAR-2029, REFERENCE NUMBER: 823148. DEVICE IMPLANTED AS PER THE MANUFACTURER CLAIM/INSTRUCTION FOR USE/USER MANUAL. PATIENT UNDERWENT SHUNT SURGERY UNDER GENERAL ANESTHESIA. INITIALLY, THE SHUNT PRESSURE WAS SET AT 110 MM H2O, WHICH WAS LATER INCREASED TO 130 MM H2O AT THE TIME OF DISCHARGE. THE PATIENT SHOWED SYMPTOMATIC IMPROVEMENT AT DISCHARGE." "HOWEVER, OVER THE PAST TWO WEEKS ON AN UNSPECIFIED DATE, SHE EXPERIENCED A RECURRENCE OF NPH SYMPTOMS (RECURRENCE OF SYMPTOMS OF URINARY INCONTINENCE, GAIT IMBALANCE AND MEMORY ISSUES) AND PATIENT WENT TO THE HOSPITAL ON (B)(6) 2025. DOCTOR ATTEMPTED TO REPROGRAM THE SHUNT TO REDUCE THE PRESSURE BACK TO 110 MM H2O. PRESSURE IN THE SYSTEM COULD NOT BE ALTERED DESPITE THESE REPEATED ATTEMPTS AND PATIENT AND WENT FOR X-RAY IMAGING. X-RAYS WERE TAKEN BOTH BEFORE AND AFTER PROGRAMMING. THE IMAGES CLEARLY SHOWE

  Patient problems: Ambulation or Postural Difficulties; Memory Loss/Impairment; Urinary Incontinence

  MAUDE report 22872262 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 3 OF 3 REPORTS (DIFFERENT PATIENTS, SAME PRODUCT FAMILY) LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00092, 3013886523-2025-00095. A PHYSICIAN REPORTED: ON AN UNSPECIFIED DATE, A PATIENT WAS IMPLANTED WITH A CODMAN HAKIM PROGRAMMABLE VALVE. ON AN UNKNOWN DATE, THE SHUNT FAILED, REQUIRING THE DOCTOR TO PERFORM ADDITIONAL SURGERY TO REPLACE IT. OUTCOME OF THE EVENT WAS UNKNOWN. CAUSALITY OF THE EVENT WAS REPORTED AS POSSIBLE WITH CODMAN HAKIM PROGRAMMABLE VALVE. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. NO CONCURRENT CONDITION WAS REPORTED. NO FAMILY HISTORY WAS REPORTED. PAST MEDICATION WAS NOT REPORTED. CONCOMITANT MEDICATION AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. NO DRUG ALLERGIES WERE REPORTED. PERTINENT LAB DATA WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21988409 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 3 REPORTS (DIFFERENT PATIENTS, SAME PRODUCT FAMILY) LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00092. 3013886523-2025-00096. A PHYSICIAN REPORTED: ON AN UNSPECIFIED DATE, A PATIENT WAS IMPLANTED WITH A CODMAN HAKIM PROGRAMMABLE VALVE. ON AN UNKNOWN DATE, THE SHUNT FAILED, REQUIRING THE DOCTOR TO PERFORM ADDITIONAL SURGERY TO REPLACE IT. OUTCOME OF THE EVENT WAS UNKNOWN. CAUSALITY OF THE EVENT WAS REPORTED AS POSSIBLE WITH CODMAN HAKIM PROGRAMMABLE VALVE. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. NO CONCURRENT CONDITION WAS REPORTED. NO FAMILY HISTORY WAS REPORTED. PAST MEDICATION WAS NOT REPORTED. CONCOMITANT MEDICATION AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. NO DRUG ALLERGIES WERE REPORTED. PERTINENT LAB DATA WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21988057 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 1 OF 3 REPORTS (DIFFERENT PATIENTS, SAME PRODUCT FAMILY) LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00095 3013886523-2025-00096. A PHYSICIAN REPORTED: ON AN UNSPECIFIED DATE, A PATIENT WAS IMPLANTED WITH A CODMAN HAKIM PROGRAMMABLE VALVE. ON AN UNKNOWN DATE, THE SHUNT FAILED, REQUIRING THE DOCTOR TO PERFORM ADDITIONAL SURGERY TO REPLACE IT. OUTCOME OF THE EVENT WAS UNKNOWN. CAUSALITY OF THE EVENT WAS REPORTED AS POSSIBLE WITH CODMAN HAKIM PROGRAMMABLE VALVE. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. NO CONCURRENT CONDITION WAS REPORTED. NO FAMILY HISTORY WAS REPORTED. PAST MEDICATION WAS NOT REPORTED. CONCOMITANT MEDICATION AND CO-SUSPECT MEDICATIONS WERE NOT REPORTED. NO DRUG ALLERGIES WERE REPORTED. PERTINENT LAB DATA WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21987892 ↗
• InjuryMay 8, 2024Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT A HAKIM VALVE/CHPV RT ANG RESERVOIR UNITIZED (ID (B)(6)) WAS IMPLANTED VIA RIGHT VENTRICULAR PERITONEAL (VP) SHUNT ON (B)(6) 2023, DUE TO HYDROCEPHALUS. A SHUNT BLOCKAGE WAS OBSERVED AS THE PATIENT EXPERIENCED HEADACHE, VOMITING, GAIT IMBALANCE, AND URINARY INCONTINENCE FOR A WEEK. AS A RESULT, SHUNT REVISION WAS PERFORMED ON (B)(6) 2024. THE PHYSICIAN WAS UNABLE TO DISCERN AN OBVIOUS REASON FOR THE SHUNT MALFUNCTION BUT PRESUMED IT WAS A BLOCKED VALVE POSSIBLE CAUSED BY MICRO-DEBRIS. IT WAS LATER REPORTED THAT THE CAUSALITY FOR THE REPORTED EVENTS WAS NOT ASSESSABLE DUE TO LACK OF INFORMATION ON CO-SUSPECT DRUGS, CONCOMITANT MEDICATIONS, COMPLETE MEDICAL HISTORY AND RELEVANT LAB INVESTIGATIONS. HOWEVER, CONCURRENT CONDITION HYDROCEPHALUS COULD BE CONFOUNDING FOR THE EVENTS VOMITING, HEADACHE, GAIT DISTURBANCE AND URINARY INCONTINENCE.

  Patient problems: Ambulation or Postural Difficulties; Headache; Vomiting

  MAUDE report 19273784 ↗