CODMAN® HAKIM® 825465Recalls & reported problems
Integra Lifesciences Production Corporation · Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD® Device High Range · Class 2 · Implant
- 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 10381780535201), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Illegible 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Illegible Information1
- Use of Device Problem1
Patient problems
- Lethargy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Use of Device Problem; Illegible Information; Use of Device Problem; Illegible Information
A FACILITY REPORTED: "A 5-YEAR-OLD PATIENT UNDERWENT SHUNT REVISION ON (B)(6) 2024 FOR RADIOLOGICAL AND CLINICAL SHUNT FAILURE. UNEVENTFUL PROCEDURE AND RECOVERED WELL OVER THE FOLLOWING DAYS. CLINICAL DETERIORATION ON (B)(6) 2024 AND SCAN DEMONSTRATED VENTRICLES ENLARGED. THEREFORE, WENT FOR ANOTHER SHUNT EXPLORATION WHICH DEMONSTRATED A NON-FUNCTIONING VALVE WHICH WAS A FIXED HIGH-PRESSURE VALVE WITH ANTISIPHON, AS OPPOSED TO A FIXED MEDIUM-LOW PRESSURE VALVE WITH ANTISIPHON. THEREFORE, THE WRONG VALVE WAS INSERTED IN THE FIRST SHUNT REVISION AND THE PATIENT REQUIRED A FURTHER PROCEDURE TO CORRECT THIS." "THERE WAS NOTHING WRONG WITH THE IMPLANT, BUT THE WRONG IMPLANT WAS INSERTED. IT IS NOT FELT TO HAVE BEEN DIRECTLY CAUSATIVE OF THIS ERROR, BUT THE LABELLING ON THE PACKAGING THAT IDENTIFIES THE TYPE OF SHUNT AND ITS PROPERTIES IS IN VERY SMALL PRINT." ADDITIONAL INFORMATION: - WHICH REFERENCE/TYPE OF VALVE WAS SUPPOSED TO BE IMPLANTED INITIALLY? "833283 MEDIUM -LOW PRESSURE". - IT WAS MENTIONED CLINICAL DETERIORATION ON (B)(6) 2024 AND SCAN DEMONSTRATED VENTRICLES ENLARGED. WHAT ARE THE CONSEQUENCES/SYMPTOMS FOR PATIENT HEALTH? "LETHARGY (IN A PATIENT WITH ALREADY REDUCED CONSC
Patient problems: Lethargy
MAUDE report 22978141 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.