CODMAN® HAKIM® 823115Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve Programmable Valve Cylindrical Valve Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) · Class 2 · Implant
All models of CODMAN HAKIM (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780519188), received between Apr 5, 2023 and Mar 30, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Improper Flow or Infusion1
- Obstruction of Flow1
Patient problems
- Cerebrospinal Fluid Leakage1
- Discomfort1
- Insufficient Information1
- Vomiting1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjurySep 5, 2024Improper Flow or Infusion; Improper Flow or Infusion
A FACILITY REPORTED A HAKIM VALVE (ID 823115) WAS IMPLANTED ON (B)(6) 2023. APPROXIMATELY 6 MONTHS AFTER IMPLANTATION, THE PATIENT SHOWED REPEATED PHASES OF VOMITING, DISCOMFORT AND DROWSINESS. THE IMAGING SHOWED NARROW VENTRICLES, SO MEDICAL STAFF SUSPECTED OVERDRAINAGE. THE VALVE OPENING PRESSURE WAS ADJUSTED, AND THE PATIENT FELT BETTER, WITH A DROP IN THE "AZ" IN THE DAYS THAT FOLLOWED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED WITH A HAKIM VALVE WITH SIPHONGUARD ON (B)(6) 2024. THE PATIENT RECOVERED.
Patient problems: Discomfort; Vomiting
MAUDE report 20150907 ↗InjuryApr 5, 2023Obstruction of Flow; Obstruction of Flow
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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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