CODMAN HAKIM SIPHONGUARD 82-3146Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve Right Angle 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) Includes: Programmable Valve, 14cm Ventricular Catheter, 120cm Peritoneal Catheter, Information Manual and Priming Adapter · Class 2 · Implant
All models of CODMAN HAKIM SIPHONGUARD (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704041535), received between Jan 20, 2022 and Nov 26, 2024 — classified as 4 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Difficult to Program or Calibrate1
- Infusion or Flow Problem1
- Obstruction of Flow1
Patient problems
- Insufficient Information3
- Cerebral Ventriculomegaly1
- Headache1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
InjuryJun 14, 2024Break; Break
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823182) WAS IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE DEVICE BROKE DUE TO PATIENT FALL. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON UNKNOWN DATE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN HOW THE VALVE FAILURE WAS DISCOVERED. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE, AND IF X-RAY TAKEN TO ASSURE NO PARTS LEFT IN PATIENT. CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19539032 ↗InjuryJun 8, 2022Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED A HAKIM VALVE ((B)(4)) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2020 WITH (B)(4). DUE TO UNDERDRAINAGE SYMPTOMS THE PATIENT VISITED THE HOSPITAL. THE FLOW OF THE VALVE WAS CONFIRMED, BUT NO IMPROVEMENT WAS SEEN EVEN IF THE PRESSURE WAS LOWERED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. THE PATIENT RECOVERED.
Patient problems: Insufficient Information
MAUDE report 14632479 ↗InjuryJan 20, 2022Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A HAKIM VALVE (ID (B)(4)) AS IMPLANTED VIA V-P SHUNT IN (B)(4) 2021 WITH SETTING 110MMH2O. ON (B)(6) 2021, THE PATIENT HAD A HEADACHE AND AN X-RAY WAS PERFORMED. VENTRICULAR ENLARGEMENT WAS CONFIRMED, SO THE VALVE SET PRESSURE WAS LOWERED TO 50 MMH2O, BUT THE VENTRICLES DID NOT SHRINK. ON (B)(4) 2021 A SHUNT CONTRAST WAS PERFORMED AND THE VALVE SYSTEM WAS SUSPECTED TO BE OBSTRUCTED; THEREFORE, ON (B)(6) 2021, THE VALVE SYSTEM WAS REMOVED AND REPLACED. THE PATIENT RECOVERED.
Patient problems: Cerebral Ventriculomegaly; Headache
MAUDE report 13308157 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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