CODMAN HAKIM 82-3110Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve Cylindrical Valve with Prechamber Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) Includes: Programmable Valve, Information Manual, Straight Connector(s) and Introducer · Class 2 · Implant
All models of CODMAN HAKIM (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704041450), received between Feb 6, 2023 and Jun 13, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Unable to Obtain Readings1
Patient problems
- Headache2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Break; Break
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823110) WAS IMPLANTED IN 2016 DUE TO SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) VIA A VENTRICULOPERITONEAL (V-P) SHUNT SET AT 50 MMH2O. ON (B)(6) 2025, THE PATIENT EXPERIENCED A HEADACHE AND VISITED THE HOSPITAL. AN X-RAY CONFIRMED THAT THE PERITONEAL CATHETER HAD RUPTURED AROUND THE NECK. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE DOCTOR ASSUMED THAT THE CATHETER HAD BEEN UNDER TENSILE FORCE, WHICH CAUSED THE RUPTURE. THE PATIENT RECOVERED.
Patient problems: Headache
MAUDE report 22202942 ↗InjuryFeb 21, 2025Break; Break
A PHYSICIAN ASSISTANT REPORTED A HAKIM VALVE (ID 823111) WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2024, THE PATIENT VISITED A PHYSICIAN, COMPLAINING OF HEADACHES. THE PATIENT FELL DOWN THE STAIRS PRIOR TO THE SHUNT ISSUE, BUT IT WAS UNCLEAR WHETHER HE HIT HIS HEAD. AN X-RAY SHUNT, SERIES AND COMPUTED TOMOGRAPHY (CT) SCAN WERE ORDERED TO ASSESS THE CONDITION OF THE SHUNT. BASED ON THE SCANS, IT WAS FOUND THAT THE HAKIM VALVE WAS BROKEN. ITS SPIRAL STAIRCASE WAS NO LONGER ATTACHED TO THE VALVE MECHANISM AND WAS FLOATING IN THE RESERVOIR OF THE VALVE. THE SHUNT LOST TENSION ON THE SPRING THAT REGULATES THE FLOW OF CEREBROSPINAL FLUID (CSF). THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024.
Patient problems: Headache
MAUDE report 21432800 ↗InjuryFeb 6, 2023Unable to Obtain Readings; Unable to Obtain Readings
A FACILITY REPORTED "THE PROGRAMMABLE VALVE COULDN'T GET PROGRAMMED ANYMORE". THE HAKIM VALVE (B)(4) WAS IMPLANTED ON (B)(6), 2009 AND EXPLANTED (B)(6), 2022; REPLACED WITH ANOTHER HAKIM VALVE. NO PATIENT SYMPTOMS REPORTED DUR TO VALVE PROGRAMMING ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16303138 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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