CODMAN HAKIMRecalls & reported problems across all models
Integra Lifesciences Production Corporation · 36 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 162
- Deaths reported
- 2
- Injuries reported
- 132
- Recalls
- 0
We found 36 models of CODMAN HAKIM by Integra Lifesciences Production Corporation in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2021 and Aug 28, 2026 — classified as 2 deaths, 132 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CODMAN HAKIM problems
Device problems
- Obstruction of Flow47
- Insufficient Device Problem Information24
- Infusion or Flow Problem12
- Fluid/Blood Leak11
- Device Difficult to Program or Calibrate10
- Break8
- Failure to Align7
- Output Problem6
Patient problems
- Insufficient Information59
- No Clinical Signs, Symptoms or Conditions25
- Headache11
- Dizziness9
- Vomiting9
- Cerebral Ventriculomegaly7
- Hydrocephalus7
- Cerebrospinal Fluid Leakage6
CODMAN HAKIM models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN® HAKIM® 823832Shunt, central nervous system and components38 reports
- CODMAN® HAKIM® 823162Shunt, central nervous system and components27 reports
- CODMAN® HAKIM® 823148Shunt, central nervous system and components14 reports
- CODMAN® HAKIM® 823164Shunt, central nervous system and components9 reports
- CODMAN® HAKIM® 823148Shunt, central nervous system and components9 reports
- CODMAN® HAKIM® 823113Shunt, central nervous system and components8 reports
- CODMAN® HAKIM® 823100Shunt, central nervous system and components7 reports
- CODMAN® HAKIM® 823110Shunt, central nervous system and components6 reports
- CODMAN® HAKIM® 823184Shunt, central nervous system and components1 death5 reports
- CODMAN® HAKIM® 823115Shunt, central nervous system and components3 reports
- CODMAN® HAKIM® 823116Shunt, central nervous system and components3 reports
- CODMAN® HAKIM® 823164Shunt, central nervous system and components3 reports
- CODMAN® HAKIM® 823114Shunt, central nervous system and components2 reports
- CODMAN® HAKIM® 823190RShunt, central nervous system and components2 reports
- CODMAN® HAKIM® 823842Shunt, central nervous system and components2 reports
- CODMAN® HAKIM® 823113Shunt, central nervous system and components2 reports
- CODMAN® HAKIM® 823162Shunt, central nervous system and components2 reports
- CODMAN® HAKIM® 823813Shunt, central nervous system and components2 reports
- CODMAN® HAKIM® 823111Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823182Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823834Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823844Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 825463Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 825483Shunt, central nervous system and components1 report
- CODMAN® HAKIM® NS0602Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823101Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823110Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823111Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823114Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823832Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823834Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823842Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 823854Shunt, central nervous system and components1 report
- CODMAN® HAKIM® 825465Shunt, central nervous system and components1 report
- CODMAN® HAKIM® NS0605Shunt, central nervous system and components1 death1 report
- CODMAN® HAKIM® NS9008Shunt, central nervous system and components1 report
Recent CODMAN HAKIM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498966 ↗OtherAug 4, 2026Improper Flow or Infusion
Patient problems: Dizziness; Headache
MAUDE report 50131234 ↗MalfunctionMar 30, 2026Fluid/Blood Leak
A FACILITY REPORTED A HAKIM VALVE (ID 823115) HAD CEREBROSPINAL FLUID LEAKAGE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24712230 ↗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 20, 2026Failure to Align
A NURSE REPORTED A HAKIM VALVE (ID 823164) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT. THE VALVE WOULD NOT REPROGRAM, THEREFORE IT WAS REMOVED AND REPLACED ON (B)(6) 2026.
Patient problems: Insufficient Information
MAUDE report 24647789 ↗InjuryMar 20, 2026Failure to Align
A FACILITY REPORTED A HAKIM VALVE (ID 823116) WAS IMPLANTED ON (B)(6) 2026, DUE TO HYDROCEPHALUS. THE VALVE ADJUSTMENT FAILED AND THE PHYSICIAN MADE A MULTIPLE ATTEMPT MORE THAN 2-3 TIMES TO ADJUST WITHOUT SUCCESS. TWO DIFFERENT ADJUSTMENT TOOLS WERE USED, BUT NEITHER WORKED. IT WAS CONFIRMED THAT THE UNIT WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 24647786 ↗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 ↗InjuryFeb 27, 2026Insufficient Device Problem Information
InjuryFeb 13, 2026Failure to Align
InjuryFeb 6, 2026Break
InjuryJan 21, 2026Break
MalfunctionJan 21, 2026Fluid/Blood Leak
InjuryJan 8, 2026Fracture
InjuryJan 8, 2026Failure to Align
InjuryJan 2, 2026Failure to Align
A FACILITY REPORTED A HAKIM VALVE (B)(6) REMAINED STUCK AT 130 MMHG, THEREFORE, IT WAS REMOVED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23943157 ↗
Other Integra Lifesciences Production Corporation products
All Integra Lifesciences Production Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page