CODMAN® HAKIM® 825483Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Precision Fixed Pressure Valve Cylindrical Right Angle Valve with SIPHONGUARD® Device, Operating Pressure: 70mm H2O (686 Pa) Medium Low Range · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780520177), received between Jan 31, 2024 and Jan 31, 2024 — classified as 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A PRECISION VALVE ( B)(6) WAS LEAKING AFTER IMPLANTATION DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE RIGHT-ANGLED BURRHOLE VALVE WAS CONNECTED TO THE PROXIMAL AND DISTAL CATHETERS AND SURGEON WAS ABOUT TO START CLOSING THE SCALP WOUND WHEN HE SAW TINY CONTINUOUS DRIPS OF CSF FROM THE SEAL CONNECTING THE MAIN BODY OF THE VALVE TO THE DISTAL END OF THE VALVE. THE EVENT LED TO 30-40 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617150 ↗
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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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