CODMAN HAKIM SIPHONGUARD 82-5463Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD Device Operating Pressure: 70mm H2O (686 Pa) Medium Low Range Includes: Precision Valve, Information Manual and Priming Adapter · Class 2 · Implant
All models of CODMAN HAKIM SIPHONGUARD (5)
Data updated Oct 16, 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 10886704041979), received between Oct 24, 2021 and Oct 24, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2021Obstruction of Flow; Obstruction of Flow
2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3014334038-2021-00212. A PHYSICIAN REPORTED A PATIENT HAD A BLOCKAGE REQUIRING REVISION SURGERY. THE BACTISEAL VENTRICULAR CATHETER AND THE CODMAN PRECISION VALVE WITH SIPHONGUARD HAVE BEEN IMPLANTED VIA VP SHUNT FOR 7 WEEKS IN A PATIENT WHO¿S BEEN TREATED FOR A TUMOR. THE PATIENT HAS NOT BEEN ACTIVE AND HE PRESENTED WITH A FLUID COLLECTION AND SYMPTOMS OF HIGH INTRACRANIAL PRESSURE. A REVISION SURGERY WAS PERFORMED AND IT WAS FOUND THAT THE VALVE IS ALMOST COMPLETELY SHEARED IN HALF. IT WAS SITTING ON THE TOP OF HIS HEAD, NOT IN A MOBILE AREA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12686924 ↗
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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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