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CODMAN® HAKIM® 823111 (REF 82-3111)Recalls & reported problems

Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve Cylindrical Valve with Prechamber and Unitized Distal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780519140), received between Mar 17, 2021 and Mar 17, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Integrity Problem” (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

  • Material Integrity Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 17, 2021Material Integrity Problem; Material Integrity Problem

    A FACILITY REPORTED A HAKIM VALVE WITH A DEFECTIVE "WHEEL ". THE PATIENT HAD A REVISION SURGERY TO REPLACE THE VALVE.

    Patient problems: Insufficient Information

    MAUDE report 11510112 ↗

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

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