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CODMAN® HAKIM® 825463Recalls & reported problems

Integra Lifesciences Production Corporation · CODMAN® HAKIM® Precision Fixed Pressure Valve Cylindrical In-Line Valve with SIPHONGUARD® Device, Operating Pressure: 70mm H2O (686 Pa) Medium Low Range · Class 2 · Implant

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 10381780520078), received between May 20, 2021 and May 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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.

Most reported problems

Device problems

  • Inaccurate Information1

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.

  • MalfunctionMay 20, 2021Inaccurate Information; Inaccurate Information

    A FACILITY REPORTED THE PATIENT ID CARD FOR A PROGRAMMABLE VALVE CAME ATTACHED TO A PRECISION VALVE. SURGEON HAD TO CHECK HE WAS PLACING THE CORRECT VALVE, CHECKING ON A RED STICKER ON THE INTERNAL PACKAGING STATING NON PROGRAMMABLE VALVE, AND ALSO VISUALLY INSPECTED THE VALVE TO ENSURE IT WAS THE CORRECT VALVE. THERE WAS NO CONSEQUENCES FOR THE PATIENT; FEW MINUTES SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11859708 ↗

Other Shunt, central nervous system and components devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.