CODMAN® HAKIM® 823100Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve, Cylindrical Valve with Prechamber · Class 2 · Implant
All models of CODMAN HAKIM (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780534457), received between Jul 26, 2024 and Aug 28, 2026 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Failure to Align1
- Insufficient Device Problem Information1
- Material Separation1
- Mechanical Problem1
- Obstruction of Flow1
- Positioning Problem1
Patient problems
- Headache3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Vomiting2
- Dizziness1
- Hydrocephalus1
- Nausea1
Recent adverse event reports
The 7 most recent of 7 reports, 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 ↗InjuryOct 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 10, 2025Mechanical Problem; Mechanical Problem
N/A.
Patient problems: Dizziness; Headache; Insufficient Information; Vomiting
MAUDE report 23266828 ↗MalfunctionSep 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
InjuryOct 4, 2024Positioning Problem; Positioning Problem
A FACILITY REPORTED A HAKIM VALVE (ID 823100) WAS IMPLANTED ON (B)(6) 2004. THE VALVE HAD "NO VISIBLE POINT", SETTING COULD NOT BE VERIFIED, VALVE COULD NOT BE SET; THEREFORE, IT WAS EXPLANTED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 20369221 ↗InjurySep 13, 2024Obstruction of Flow; Obstruction of Flow
InjuryJul 26, 2024Failure to Align; Failure to Align
A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2024 WITH A PRESSURE OF 130 MMH2O. ON (B)(6) 2024 THE VALVE WAS REPROGRAMMED TO 160 MMH2O. EIGHTEEN DAYS AFTER IMPLANTATION, THE PATIENT PRESENTED WITH HEADACHE, NAUSEA AND VOMITING, THEREFORE, MEDICAL STAFF WANTED TO ADJUST THE VALVE AT A NEW PRESSURE OF 200 MMH2O, BUT THEY COULD NOT PERFORM THE ADJUSTMENT EVEN WITH MANY ATTEMPTS. SO THEY DECIDED TO EXPLANT THE VALVE THINKING THAT IT WAS BLOCKED. A NEW HAKIM VALVE WAS IMPLANTED (SETTING 140) AND THE PATIENT RECOVERED.
Patient problems: Headache; Nausea; Vomiting
MAUDE report 19838997 ↗
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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 14, 2026 · each report above links to its original FDA record
- 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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