CODMAN® HAKIM® 823182Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® HAKIM® Programmable Valve Right Angle Valve with SIPHONGUARD® Device 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780519256), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Break; Break
A FACILITY REPORTED THE CONNECTION BETWEEN A HAKIM VALVE (ID823182) AND THE SIPHON GUARD WAS SHAKY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE AND THE EVENT LED TO 30 MINUTES SURGICAL DELAY. IT WAS CONFIRMED THAT THE ISSUE WAS FOUND DURING THE IMPLANTATION, BEFORE IMPLANTATION SITE CLOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160758 ↗
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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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