CODMAN® HAKIM® 823832 (REF 82-3832)Recalls & reported problems
Integra Lifesciences Production Corporation · Programmable Valve In-line Valve with SIPHONGUARD™ Device · 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 10381780535034), received between Jul 19, 2024 and Jul 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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
- Excess Flow or Over-Infusion1
Patient problems
- Dizziness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2024 WITH SETTING 100MMH2O. ON MAY 7, 2024, THE PATIENT FELT DIZZY, AND ON MAY 13, 2024, THE PATIENT WENT TO THE HOSPITAL AGAIN AND A LUMBAR PUNCTURE WAS DONE WITH THE INTRACRANIAL PRESSURE (ICP) PRESSURE OF 80MMH2O. THE COMPUTED TOMOGRAPHY (CT) SHOWED SLIT VENTRICLE, AND SUSPECTED THERE WAS A CSF OVER-DRAIN. THE PRESSURE WAS ADJUSTED TO HIGHEST VALUE WHILE THE ICP OF THE PATIENT WAS STILL LOWER TO NORMAL VALUE. THE VALVE REMAINS IMPLANTED.
Patient problems: Dizziness
MAUDE report 19780337 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.