CODMAN® HAKIM® 823834 (REF 82-3834)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve In-Line Valve Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) · 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 10381780519812), received between Jun 18, 2025 and Jun 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “No 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
- No Flow1
Patient problems
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025No Flow; No Flow
A FACILITY REPORTED A HAKIM VALVE (ID 823834) WAS IMPLANTED IN 2018. IN (B)(6) 2025, THE PATIENT PRESENTED WITH HEADACHE, AND THERE WAS A TOTAL BLOCK OF DRAINAGE, THEREFORE, DUE TO SUSPICION OF OBSTRUCTION, IT WAS REMOVED AND REPLACED. WHEN THE VALVE WAS EXPLANTED IT WAS FOUND TO BE BROKEN. THE PATIENT RECOVERED.
Patient problems: Headache
MAUDE report 22283337 ↗
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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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