CODMAN® HAKIM® 823842 (REF 82-3842)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve In-Line Valve with SIPHONGUARD® Device 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 10381780519836), received between Jul 26, 2023 and May 24, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
- Pressure Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Dizziness1
- Hydrocephalus1
- Nausea1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Pressure Problem; Pressure Problem
A FACILITY REPORTED A HAKIM VALVE (ID (B)(6)) WAS IMPLANTED IN (B)(6) 2024. AFTER SOME WEEKS OF COMPLAINTS AND SEVERAL PRESSURE CHANGES , THE SURGEON CONCLUDED THAT THE VALVE WAS NOT WORKING, THEREFORE, 10 WEEKS AFTER IMPLANTATION, THE VALVE WAS REMOVED AND REPLACED FOR A CERTAS PLUS. THE PATIENT IS DOING GOOD.
Patient problems: Ambulation or Postural Difficulties; Dizziness; Nausea; No Clinical Signs, Symptoms or Conditions
MAUDE report 19391944 ↗InjuryJul 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
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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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