CODMAN HAKIM 82-3012Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Prechamber Operating Pressure: 40mm H2O Plus or Minus 10mm H2O (392 Pa Plus or Minus 98 Pa) Low Range Includes: Precision Valve, Information Manual, Straight Connector(s) and Introducer · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10886704041061), received between Nov 17, 2023 and Nov 17, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2023Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2021. THE PATIENT HAD REVISION SURGERY TWICE ON (B)(6) 2023 AND (B)(6) 2023. DUE TO SUSPECTED OCCLUSION OF THE SP SHUNT, AN ATTEMPT TO CHANGE THE SETTING WAS PERFORMED BUT WAS UNABLE TO CHANGE AND SUBDURAL SPACE DID NOT BECOME SMALLER. THEREFORE, THE VALVE WAS REMOVED ON (B)(6) 2023, AND A 30 MINUTE DELAY WAS NOTED. PROTEIN CONCENTRATION: 156. THE PATIENT PRIMARY DISEASE IS SUSPECTED INTERHEMISPHERIC FISSURE CYST. THE PATIENT RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159898 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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