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CODMAN HAKIM NS5034Recalls & reported problems

Cerenovus, Inc. · CODMAN HAKIM Programmable Valve Cylindrical Valve with Integral Connector(s) Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Programmable Valve, Introducer and Information Manual · 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 10886704046653), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • InjuryDec 6, 2022Break; Break

    A FACILITY REPORTED A PATIENT HAD A PERITONEAL VALVE (ID NS5034) IMPLANTED ON (B)(6) 2020. MRI SHOWED TOTAL RESOLUTION OF PERICEREBRAL EFFUSION SO THEY DECIDED TO CHANGE THE FLOW OF THE VALVE SLOWLY: ON (B)(6) 2022 IT WAS 70 MMH2O / ON (B)(6) 2022 IT WAS 80 MMH2O. ON (B)(6) 2022 THEY WANTED 90 MMH2O BUT THE VALVE WAS BLOCKED AT 80 MMH2O. MEDICAL STAFF DECIDED TO DO A REVISION ON (B)(6) 2022. THE VALVE WAS BROKEN.

    Patient problems: Insufficient Information

    MAUDE report 15928159 ↗

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.