CODMAN® HAKIM® 823164 (REF 82-3164)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve In-Line Valve Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10381780519249), received between Jun 14, 2022 and Jan 8, 2026 — classified as 8 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow4
- Insufficient Device Problem Information2
- Failure to Align1
- Infusion or Flow Problem1
- Output Problem1
Patient problems
- Insufficient Information4
- Convulsion/Seizure1
- Decreased Appetite1
- Dizziness1
- Failure of Implant1
- Fever1
- High Blood Pressure/ Hypertension1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2026Failure to Align
InjuryOct 17, 2025Obstruction of Flow; Obstruction of Flow
InjuryAug 21, 2025Output Problem; Output Problem
InjuryJun 13, 2025Infusion or Flow Problem; Infusion or Flow Problem
InjuryJun 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
N/A.
Patient problems: Convulsion/Seizure; Fever; High Blood Pressure/ Hypertension
MAUDE report 22159957 ↗InjuryNov 26, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A MALFUNCTION DURING THE USE OF CODMAN PROGRAMMABLE INLINE VALVE. "ON (B)(6) 2024, A PHYSICIAN IMPLANTED CODMAN PROGRAMABLE INLINE VALVE (ID 823164). THE LOT/BATCH NUMBER AND EXPIRY DATE WERE NOT REPORTED. THE DEVICE WORKED FOR 24 HOURS ONLY THEN AUTOMATICALLY STOPPED/BLOCKED (MALFUNCTION OF SHUT CHAMBER). WHILE WORKING THROUGH DIGITALLY, IT WAS FUNCTIONING BUT NOT SPONTANEOUSLY, EVEN AFTER THE PRESSURE WAS REDUCED TO 70 MM/ H²O BY THE PHYSICIAN. IT WAS REPORTED THAT, THERE WAS NO CSF DRAINAGE. PHYSICIAN HAD TO REMOVE THE SHUNT AND CONVERT IT INTO AN EVD." REMARKS: "THE CAUSALITY FOR THE REPORTED EVENT IS CONSIDERED AS NOT ASSESSABLE DUE TO LACK OF INFORMATION REGARDING CIRCUMSTANCES LEADING TO THE EVENT, CO-SUSPECTS, CONCOMITANT MEDICATIONS, INDICATION, CONCURRENT CONDITIONS, RELEVANT MEDICAL HISTORY AND PAST DRUG HISTORY FOR COMPLETE ASSESSMENT."
Patient problems: Insufficient Information
MAUDE report 20783733 ↗MalfunctionNov 15, 2024Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED THAT AFTER IMPLANTATION OF A HAKIM VALVE (ID 823164) DURING PROCEDURE, CEREBROSPINAL FLUID (CSF) DID NOT FLOW OUT. THE VALVE WAS REPLACED, AND THE FLOW OCCURRED WITHOUT ANY ISSUES AFTER THE REPLACEMENT. THE EVENT HAPPENED BEFORE IMPLANTATION SITE CLOSURE, NO PATIENT INJURY REPORTED; HOWEVER, THE EVENT LED TO 30 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694709 ↗InjuryJul 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJun 14, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823164) WAS IMPLANTED VIA V-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTINGS TO TREAT A MIDLINE FISSURE CYST. A CATHETER COMING FROM THE EPIDURAL AND A CATHETER COMING FROM THE VENTRICLE WERE CONNECTED WITH A Y-SHAPED CONNECTOR AND CONNECTED TO THE VALVE. AN OBSTRUCTION WAS SUSPECTED THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS.
Patient problems: Failure of Implant
MAUDE report 14687893 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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