CODMAN® HAKIM® 823184Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve Right Angle 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
- 5
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780519263), received between Jan 5, 2023 and Nov 22, 2024 — classified as 1 death, 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (3 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 Flow3
- Infusion or Flow Problem1
- Insufficient Device Problem Information1
Patient problems
- Cerebral Ventriculomegaly1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Myocardial Infarction1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Infusion or Flow Problem; Infusion or Flow Problem
DeathSep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJul 27, 2023Obstruction of Flow; Obstruction of Flow
InjuryMar 3, 2023Obstruction of Flow; Obstruction of Flow
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00072. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823184) AND A BACTISEAL CATHETER KIT (ID 823072) WERE IMPLANTED ON (B)(6) 2022. A SHUNT BLOCKAGE AND MALFUNCTION OCCURRED ON FEBRUARY 07, 2023. THE PATIENT HAD INTERVENTRICULAR HEMORRHAGE ON THE FIFTH (5TH) DAY AFTER IMPLANTATION. DUE TO BLOCKAGE AND MALFUNCTION THE VALVE AND THE CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2023.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16478262 ↗InjuryJan 5, 2023Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A HAKIM VALVE (ID 823184) WAS IMPLANTED ON (B)(6), 2022. A SHUNT BLOCKAGE OR MALFUNCTION WAS OBSERVED. THE PATIENT EXPERIENCED ENLARGED VENTRICLES DUE TO UNDERDRAINAGE APPROXIMATELY 2 TO 3 WEEKS AFTER IMPLANTATION. DUE TO PRODUCT ISSUE THE VALVE WAS REMOVED ON (B)(6), 2022.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 16109054 ↗
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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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