CODMAN® HAKIM® 823114 (REF 82-3114)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve Micro Valve and Unitized Distal Catheter Programmable in steps of 10mm H2O (98 Pa): 30mm H2O to 200mm H2O (294 Pa - 1960 Pa) · Class 2 · Implant
All models of CODMAN HAKIM (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780519171), received between Jul 26, 2024 and Nov 26, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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
- Infusion or Flow Problem1
- No Flow1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2024Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) IMPLANTED ON (B)(6) 2024 STOPPED DRAINING. THEREFORE THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THE PATIENT IS STABLE.
Patient problems: Insufficient Information
MAUDE report 20786809 ↗InjuryJul 26, 2024No Flow; No Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED ON (B)(6) 2023. IT STOPPED DRAINING, THEREFORE, THE VALVE WAS REPLACED ON (B)(6) 2024. THE PATIENT IS DOING WELL. ACCORDING TO INFORMATION PROVIDED, IT IS NOT KNOWN IF THERE WAS AN OBSTRUCTION.
Patient problems: Insufficient Information
MAUDE report 19838983 ↗
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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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