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CODMAN HAKIM 82-3008Recalls & reported problems

Cerenovus, Inc. · CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Prechamber and Unitized Distal Catheter Operating Pressure: 70mm H2O Plus or Minus 10mm H2O (686 Pa Plus or Minus 98 Pa) Medium Low Range Includes: Precision Valve, 14cm Ventricular Catheter, 120cm Unitized Peritoneal Catheter, Information Manual, Straight Connector, Introducer and Right Angle Adapter · 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 10886704041023), received between Jul 31, 2018 and Jul 31, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (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

  • Obstruction of Flow1

Patient problems

  • Neurological Deficit/Dysfunction1

Recent adverse event reports

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

  • InjuryJul 31, 2018Obstruction of Flow; Obstruction of Flow

    AS REPORTED BY THE SALES REP, AFTER TWO WEEKS AFTER INSERTION IN TO A CANINE PATIENT, IN AN OFF-LABEL APPLICATION, THE HAKIM PRECISION VALVE BECAME OBSTRUCTED AND WAS REVISED. THE DOG IS DOING WELL POST-REVISION.

    Patient problems: Neurological Deficit/Dysfunction

    MAUDE report 7736250 ↗

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.