CODMAN HAKIM 82-3284Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Precision Fixed Pressure Valve Right Angle Valve and Unitized Distal Catheter Operating Pressure: 100mm H2O Plus or Minus 10mm H2O (980 Pa Plus or Minus 98 Pa) Medium High Range Includes: Precision Valve, 14cm Ventricular Catheter, 120cm Unitized Peritoneal Catheter, Information Manual and Priming Adapter · 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 10886704041696), received between Mar 17, 2021 and Mar 17, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THE PATIENT HAD AN UNKNOWN ALLERGY AFTER A HAKIM VALVE PLACEMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11510109 ↗
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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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