Skip to content

CODMAN® HAKIM® NS9008Recalls & reported problems

Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve, In-Line Valve with SiphonGuard and Unitized Distal Catheter · 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 10381780535775), received between Sep 19, 2023 and Sep 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Pressure 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

  • Pressure Problem1

Patient problems

  • Confusion/ Disorientation1

Recent adverse event reports

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

  • InjurySep 19, 2023Pressure Problem; Pressure Problem

    A PHYSICIAN REPORTED A HAKIM VALVE (NS9008) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2019 WITH UNKNOWN SETTING. ON (B)(6) 2023, THE PATIENT PRESENTED WITH DISORIENTATION AND AN X-RAY WAS PERFORMED. UNDERDRAINAGE AND SLIT-LIKE VENTRICLE WERE OBSERVED. DUE TO THE SET PRESSURE COULD NOT BE CHANGED, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2023. THE PATIENT IS IN THE FOLLOW- UP.

    Patient problems: Confusion/ Disorientation

    MAUDE report 17776326 ↗

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.