CODMAN HAKIMRecalls & reported problems across all models
Cerenovus, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls
- 0
We found 17 models of CODMAN HAKIM by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2018 and Aug 14, 2025 — classified as 47 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (10 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 Flow10
- Break6
- Insufficient Device Problem Information6
- Infusion or Flow Problem5
- Device Difficult to Program or Calibrate4
- Overheating of Device4
- Adverse Event Without Identified Device or Use Problem3
- Excess Flow or Over-Infusion3
Patient problems
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions11
- Hydrocephalus5
- Ambulation or Postural Difficulties3
- Failure of Implant3
- No Known Impact Or Consequence To Patient3
- Cerebral Ventriculomegaly2
- Headache2
CODMAN HAKIM models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN HAKIM 82-3114Shunt, central nervous system and components7 reports
- CODMAN HAKIM 82-3164Shunt, central nervous system and components6 reports
- CODMAN HAKIM 82-3190Shunt, central nervous system and components6 reports
- CODMAN HAKIM 82-3111Shunt, central nervous system and components5 reports
- CODMAN HAKIM 82-3184Shunt, central nervous system and components5 reports
- CODMAN HAKIM 82-3834Shunt, central nervous system and components5 reports
- CODMAN HAKIM 82-3112Shunt, central nervous system and components4 reports
- CODMAN HAKIM 82-3110Shunt, central nervous system and components3 reports
- CODMAN HAKIM 82-3148Shunt, central nervous system and components3 reports
- CODMAN HAKIM 82-3807Shunt, central nervous system and components2 reports
- CODMAN HAKIM 82-3844Shunt, central nervous system and components2 reports
- CODMAN HAKIM 82-3008Shunt, central nervous system and components1 report
- CODMAN HAKIM 82-3012Shunt, central nervous system and components1 report
- CODMAN HAKIM 82-3115Shunt, central nervous system and components1 report
- CODMAN HAKIM 82-3284Shunt, central nervous system and components1 report
- CODMAN HAKIM 82-5473Shunt, central nervous system and components1 report
- CODMAN HAKIM NS5034Shunt, 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.
InjuryAug 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJun 24, 2025Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information
InjuryJun 13, 2025Break; Break
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823110) WAS IMPLANTED IN 2016 DUE TO SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) VIA A VENTRICULOPERITONEAL (V-P) SHUNT SET AT 50 MMH2O. ON (B)(6) 2025, THE PATIENT EXPERIENCED A HEADACHE AND VISITED THE HOSPITAL. AN X-RAY CONFIRMED THAT THE PERITONEAL CATHETER HAD RUPTURED AROUND THE NECK. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE DOCTOR ASSUMED THAT THE CATHETER HAD BEEN UNDER TENSILE FORCE, WHICH CAUSED THE RUPTURE. THE PATIENT RECOVERED.
Patient problems: Headache
MAUDE report 22202942 ↗InjuryMay 28, 2025No Flow; No Flow
InjuryMar 28, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A FACILITY REPORTED: THE PATIENT HAD AN MRI DONE AND THE SURGEON SEEMS TO THINK IT AFFECTED THE SETTINGS OF THE HAKIM VALVE (ID (B)(6)). WITH NUMEROUS ATTEMPTS THEY HAVE NOT BEEN ABLE TO READJUST THE SETTINGS SINCE, THEREFORE, THE VALVE WAS REMOVED AND REPLACED. THE PATIENT WAS NOT EXPOSED TO SIGNIFICANT ACCELERATION OR DECELERATION SUCH AS A CAR ACCIDENT OR FALL. THE VALVE WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 21721033 ↗InjuryFeb 21, 2025Break; Break
A PHYSICIAN ASSISTANT REPORTED A HAKIM VALVE (ID 823111) WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2024, THE PATIENT VISITED A PHYSICIAN, COMPLAINING OF HEADACHES. THE PATIENT FELL DOWN THE STAIRS PRIOR TO THE SHUNT ISSUE, BUT IT WAS UNCLEAR WHETHER HE HIT HIS HEAD. AN X-RAY SHUNT, SERIES AND COMPUTED TOMOGRAPHY (CT) SCAN WERE ORDERED TO ASSESS THE CONDITION OF THE SHUNT. BASED ON THE SCANS, IT WAS FOUND THAT THE HAKIM VALVE WAS BROKEN. ITS SPIRAL STAIRCASE WAS NO LONGER ATTACHED TO THE VALVE MECHANISM AND WAS FLOATING IN THE RESERVOIR OF THE VALVE. THE SHUNT LOST TENSION ON THE SPRING THAT REGULATES THE FLOW OF CEREBROSPINAL FLUID (CSF). THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024.
Patient problems: Headache
MAUDE report 21432800 ↗InjuryOct 31, 2024Positioning Failure; Positioning Failure
InjuryAug 27, 2024Pressure Problem; Pressure Problem
InjuryAug 2, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
A PHYSICIAN REPORTED AN 80-YEAR-OLD MALE PATIENT WHO HAD SHUNT MALFUNCTION, URINARY INCONTINENCE, CEREBROSPINAL FLUID RETENTION, MOVEMENT DISORDER, SLEEP EXCESSIVE, MEMORY DEFICIT DURING THE USE OF HAKIM VALVE (ID (B)(6)) FOR NORMAL PRESSURE HYDROCEPHALUS INDICATION. NOT REPORTED: PATIENT MEDICAL HISTORY, FAMILY HISTORY, PAST MEDICATION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION AND RELEVANT LAB DATA. ON (B)(6) 2024, THE PATIENT WAS PLACED WITH HAKIM VALVE. ON AN UNKNOWN DATE, PATIENT DEVELOPED SYMPTOMS SUCH AS URINARY INCONTINENCE, INCREASED SLEEPINESS (HYPERSOMNIA) AND MEMORY DEFICIT (MEMORY IMPAIRMENT). THE PHYSICIAN ADVISED REDUCING THE VALVE PRESSURE TO 130 MM. IT WAS ATTEMPTED TO REPROGRAM THE VALVE FROM 150 MM TO 130 MM, BUT THE VALVE GOT STUCK AT 50/60/70 MM LEVELS. ON (B)(6) 2024 AND (B)(6) 2024, THE PHYSICIAN TRIED MULTIPLE ATTEMPTS TO PROGRAM IT, EVEN PLACING THE PROGRAMMING DEVICE AT DIFFERENT ANGLES, IT DID NOT HELP. PHYSICIAN TRIED TO PROGRAM THE UNOPENED DEVICE AND IT WORKED. SO, IT WAS CONCLUDED MALFUNCTIONING OF THE VALVE. THIS CAUSED COLLECTION OF FLUID BETWEEN THE BRAIN AND SKULL (CEREBROSPINAL FLUID RETENTION). LIMB MOVEMENTS ARE AFFECTED ON THE LEFT SIDE (M
Patient problems: Memory Loss/Impairment; Sleep Dysfunction; Urinary Incontinence
MAUDE report 19893077 ↗InjuryAug 2, 2024Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED A HAKIM VALVE (UNKNOWN ID) CEASED TO DRAIN. THEREFORE, THE PHYSICIAN IMPLANTED A NEW VALVE FROM A DIFFERENT BRAND. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: Insufficient Information
MAUDE report 19893076 ↗InjuryJun 21, 2024Infusion or Flow Problem; Infusion or Flow Problem
N/A.
Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation
MAUDE report 19590355 ↗InjuryMar 24, 2024Pressure Problem; Pressure Problem
A PHYSICIAN REPORTED A SHUNT MALFUNCTIONING ON A HAKIM VALVE (ID 823148) AFTER DOING MAGNETIC RESONANCE IMAGING (MRI). A 80 YEAR-OLD MALE PATIENT WITH A CASE OF NORMAL PRESSURE HYDROCEPHALUS FOR WHICH PROGRAMMABLE VENTRICULOPERITONEAL (VP) SHUNT WAS DONE IN (B)(6) 2018. THE PATIENT WAS DOING ALRIGHT BUT READMITTED IN THE HOSPITAL IN (B)(6) 2023 FOR A SUSPECTED ISCHEMIC STROKE. A MAGNETIC RESONANCE IMAGING (MRI) BRAIN (PAIN) WAS PERFORMED 1.5 T MACHINE. THE SHUNT VALVE OPENING PRESSURE WAS KEPT DURING SURGERY AT 120MM H20, AND A PATIENT WAS DISCHARGED AFTER IT WAS RESET TO 120 MM H20. ON (B)(6) 2023, HE WAS ADMITTED AGAIN WITH BILATERAL MASSIVE SUBDURAL HEMORRHAGE FOR WHICH EMERGENCY SURGERY WAS DONE TO EVACUATE THE BLOOD IN THE ODD HOUR. IT WAS PRESUMED THAT THERE WAS OVERDRAINAGE OF CEREBROSPINAL FLUID (CSF), THEREFORE SHUNT TUBE WAS TIED AT THE CHEST WALL SO THAT NO CEREBROSPINAL FLUID (CSF) CAN FLOW SINCE NO TECHNICIAN WAS AVAILABLE TO RESET THE SHUNT. A PATIENT IMPROVED LATER AND WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6), 2024, HE WAS ADMITTED AGAIN WITH DROWSINESS AND A COMPUTED TOMOGRAPHY (CT) BRAIN SHOWED VENTRICULOMEGALY. AN X-RAY PERFORMED TO SEE THE VALVE OPENING PRESSU
Patient problems: Cerebral Ventriculomegaly; Intracranial Hemorrhage
MAUDE report 18966522 ↗InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2024Break; Break
A SALES REPRESENTATIVE REPORTED: "ON (B)(6) 2022, THE PATIENT HAD HYDROCEPHALUS SYMPTOMS AND A DESTROYED MECHANISM WAS SEEN ON X-RAY. THEY TALKED ABOUT IT AS PART OF A FURTHER TRAINING COURSE." THE VALVE WAS IMPLANTED ON (B)(6) 2013; EXPLANTED AND REPLACED ON (B)(6) 2024. THE BOY HAS HAD A TOTAL OF 7 MRIS IN HIS LIFE, THE LAST ONE WAS ON (B)(6) 2024. THE VALVE DEFECT ALSO OCCURRED DURING THIS TIME.
Patient problems: Hydrocephalus
MAUDE report 18841821 ↗InjuryMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
Other Cerenovus, Inc. products
- GALAXY G358 models · 1,386 reports · 1 recall
- CODMAN41 models · 107 reports · 22 recalls
- MICRUSFRAME47 models · 298 reports
- DELTAFILL29 models · 294 reports
- CEREPAK FREEFORM60 models · 166 reports · 1 recall
- CEREBASE3 models · 143 reports · 1 recall
- DELTAXSFT13 models · 130 reports
- CEREPAK UNIFORM58 models · 33 reports · 1 recall
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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