CODMAN HAKIM SIPHONGUARDRecalls & reported problems across all models
Cerenovus, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls
- 0
We found 5 models of CODMAN HAKIM SIPHONGUARD by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2018 and Jan 21, 2026 — classified as 53 injuries, 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (18 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CODMAN HAKIM SIPHONGUARD problems
Device problems
- Obstruction of Flow18
- Insufficient Device Problem Information10
- Pressure Problem8
- Adverse Event Without Identified Device or Use Problem4
- Break3
- Infusion or Flow Problem3
- Device Difficult to Program or Calibrate2
- Crack1
Patient problems
- Insufficient Information18
- Cerebral Ventriculomegaly9
- Headache5
- Failure of Implant4
- Hydrocephalus4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Fever3
- No Clinical Signs, Symptoms or Conditions3
CODMAN HAKIM SIPHONGUARD models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN HAKIM SIPHONGUARD 82-3832Shunt, central nervous system and components22 reports
- CODMAN HAKIM SIPHONGUARD 82-3842Shunt, central nervous system and components15 reports
- CODMAN HAKIM SIPHONGUARD 82-3162Shunt, central nervous system and components12 reports
- CODMAN HAKIM SIPHONGUARD 82-3146Shunt, central nervous system and components4 reports
- CODMAN HAKIM SIPHONGUARD 82-5463Shunt, central nervous system and components1 report
Recent CODMAN HAKIM SIPHONGUARD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Obstruction of Flow
InjuryJan 2, 2026Insufficient Device Problem Information
InjurySep 12, 2025Obstruction of Flow; Obstruction of Flow
N/A.
Patient problems: Ambulation or Postural Difficulties; Cerebral Ventriculomegaly
MAUDE report 23037622 ↗InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00138. EVENT FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED THAT A HAKIM VALVE (ID 823832) AND BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2021. THE PATIENT WAS ADMITTED TWO MONTHS AFTER UNDERGOING SURGERY FOR A BRAINSTEM CAVERNOUS HEMANGIOMA. COMPREHENSIVE EXAMINATIONS WERE PERFORMED UPON ADMISSION. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ALTERED MENTAL STATUS AND INTERMITTENT FEVER, SUGGESTING RETROGRADE INTRACRANIAL INFECTION SECONDARY TO ABDOMINAL INFECTION. DUE TO RECURRENT SYMPTOMS, A VP SHUNT REVISION WAS PERFORMED ON (B)(6) 2022, DURING WHICH THE ABDOMINAL END OF THE SHUNT CATHETER WAS EXTERNALIZED AND CONNECTED TO A DRAINAGE BAG. POSTOPERATIVE FINDINGS: CEREBROSPINAL FLUID (CSF) SMEAR REVEALED GRAM-POSITIVE COCCI, PROMPTING CENTRAL NERVOUS SYSTEM (CNS) ANTIBIOTIC THERAPY. BY JANUARY 25, 2022, THE PATIENT REPORTED NO SIGNIFICANT DISCOMFORT AND SHOWED SATISFACTORY RECOVERY, LEADING TO DISCHARGE ON THE SAME DAY. SUBSEQUENT ADMISSION (TWO MONTHS POST-SHUNT): THE PATIENT WAS READMITTED ON (B)(6) 2022, WITH PROGRESSIVE CONSCIOUSNESS DISTURBANCE OVER TWO DAYS. AN EXTERNAL HEAD CT INDICAT
Patient problems: Altered State of Consciousness; Bacterial Infection; Fever
MAUDE report 22201646 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00126. 3013886523-2025-00127. EVENT FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A HAKIM VALVE (ID 823832), A VENTRICULAR BACTISEAL CATHETER (ID 823073) AND A PERITONEAL BACTISEAL CATHETER (ID 823074) WERE IMPLANTED ON (B)(6) 2020. THE PATIENT WAS ADMITTED TO THE PEDIATRIC IMMUNOLOGY AND NEPHROLOGY DEPARTMENT FOR TREATMENT ON(B)(6) 2020. THE CHIEF COMPLAINT WAS INTERMITTENT FEVER AND COUGH MORE THAN HALF A MONTH. AFTER TREATMENT, THE CHILD'S FEVER GRADUALLY IMPROVED, BUT THE SUBCUTANEOUS EFFUSION IN THE OCCIPITAL REGION DID NOT IMPROVE. THEREFORE, ON (B)(6) 2020, AN EXPLORATION AND ADJUSTMENT OF THE OCCIPITAL CISTERN SHUNT TUBE WAS PERFORMED. THE OPERATION WENT SMOOTHLY. AFTER THE OPERATION, LOCAL COMPRESSION BANDAGING WAS GIVEN, AND THE CHILD RECOVERED SMOOTHLY AND WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2020, THE PATIENT HAD RECURRENT FEVER, AND ON (B)(6) 2020, THE 0MNAY SAC WAS IMPLANTED AND THE VENTRICLE WAS PERFORMED UNDER GENERAL ANESTHESIA. THE ABDOMINAL SHUNT TUBE REMOVAL SURGERY WENT SMOOTHLY. ANTI-INFECTION, ANTI-INFLAMMATORY AND ANTIFEVER TREATMENT, AS WELL AS FLUID REPLACEMENT THERAPY W
Patient problems: Fever; Unspecified Infection
MAUDE report 22158994 ↗InjuryMay 28, 2025No Flow; No Flow
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00119. EVENT REPORTED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A PATIENT UNDERWENT CEREBRAL ANEURYSM CLIPPING DUE TO ANEURYSM RUPTURE FROM ON (B)(6) 2021. POSTOPERATIVELY, HYDROCEPHALUS OCCURRED, THEREFORE, A HAKIM VALVE (ID: 823832) AND A BACTISEAL CATHETER (ID: 823072) WERE IMPLANTED ON (B)(6) 2021. A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2022 INDICATED THAT THERE WAS A POSSIBILITY OF INSUFFICIENT POWER IN THE DRAINAGE SYSTEM. AFTER LOWERING THE PRESSURE OF THE SHUNT VALVE, THERE WAS NO IMPROVEMENT, THEREFORE AN OBSTRUCTION WAS CONSIDERED AND A LATERAL VENTRICULOPERITONEAL ADJUSTMENT SURGERY WAS PERFORMED ON (B)(6) 2022. PRODUCT WAS REMOVED AND REPLACED WITH ANOTHER BRAND. PATIENT RECOVERED.
Patient problems: Hydrocephalus
MAUDE report 22097271 ↗InjuryMay 1, 2025Infusion or Flow Problem; Infusion or Flow Problem
InjuryJan 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryDec 27, 2024Output Problem; Output Problem
InjuryDec 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2024 DUE TO SHUNT DYSFUNCTION. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT PRESENTED SIGNS AND SYMPTOMS DUE TO SHUNT DYSFUNCTION. PRIMARY DISEASE: SLIT VENTRICLE SYNDROME.
Patient problems: Insufficient Information
MAUDE report 20926262 ↗InjuryNov 26, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
Other Cerenovus, Inc. products
- GALAXY G358 models · 1,386 reports · 1 recall
- CODMAN41 models · 107 reports · 22 recalls
- MICRUSFRAME47 models · 298 reports
- DELTAFILL29 models · 294 reports
- CEREPAK FREEFORM60 models · 166 reports · 1 recall
- CEREBASE3 models · 143 reports · 1 recall
- DELTAXSFT13 models · 130 reports
- CEREPAK UNIFORM58 models · 33 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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