CODMAN® HAKIM® 823164 (REF 82-3164)Recalls & reported problems
Integra Lifesciences Production Corporation · Programmable Valve In-line Valve · Class 2 · Implant
All models of CODMAN HAKIM (36)
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 10381780534587), received between Oct 2, 2025 and Mar 20, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Align” (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. 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
- Failure to Align1
- Fluid/Blood Leak1
- Unintended System Motion1
Patient problems
- Insufficient Information2
- Cerebrospinal Fluid Leakage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Failure to Align
A NURSE REPORTED A HAKIM VALVE (ID 823164) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT. THE VALVE WOULD NOT REPROGRAM, THEREFORE IT WAS REMOVED AND REPLACED ON (B)(6) 2026.
Patient problems: Insufficient Information
MAUDE report 24647789 ↗InjuryOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 2, 2025Unintended System Motion; Unintended System Motion
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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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