CODMAN HAKIM SIPHONGUARD 82-3832Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886704041825), received between Jul 31, 2018 and Sep 12, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (7 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, 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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

  N/A.

  Patient problems: Headache

  MAUDE report 22202589 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22202588 ↗
• InjuryJun 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 22202120 ↗
• 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

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 22201644 ↗
• 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 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3013886523-2024-00175: A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD FEVER AND CEREBROSPINAL FLUID (CSF) TESTED POSITIVE. THEREFORE, THE PATIENT RECEIVED AN ANTI-INFECTIVE THERAPY. ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND THE DEVICES WERE EXPLANTED AND REPLACED WITH A NEW HAKIM VALVE (ID 823832) AND THE BACTISEAL CATHETER (ID 823072).

  Patient problems: Unspecified Infection

  MAUDE report 19588552 ↗
• InjuryApr 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED VIA VENTRICULO-PERITONEAL (VP) SHUNT IN 2016 WITH UNKNOWN SETTING. THE PATIENT VISITED THE OUTPATIENT CLINIC ON MARCH 23, 2023 WITH HEADACHE. THEN SHE VISITED AGAIN ON (B)(6) 2023. AN IMAGING DIAGNOSIS CONFIRMED FURTHER EXTREME VENTRICULOMEGALY AND WITH HEADACHE. THE ENTIRE SHUNT SYSTEM WAS CHECKED, 3DCT SHOWED THAT THE CATHETER AT THE PROXIMAL END OF THE VALVE WAS ALMOST TORN AND SLIGHTLY CONNECTED. ON (B)(6) 2023, ONLY THE TORN PORTION OF THE PROXIMAL CATHETER WAS REMOVED, AND THE PROXIMAL CATHETER WAS RECONNECTED TO THE VALVE, LIGATED AGAIN, AND THE OPERATION WAS COMPLETED. THE VALVE REMAINS IMPLANTED.

  Patient problems: Headache

  MAUDE report 16765718 ↗
• InjuryJan 12, 2023Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6)2022 . DURING THE MONTH OF (B)(6)2022 , THE VALVE COULD NOT BE PROGRAMMED. THEN THE PATIENT HAD A REVISION PROCEDURE ON (B)(6)2022 WITH A NEW HAKIM VALVE. AT THE TIME OF THE PROCEDURE, THE RETRIEVED CATHETER WAS FOUND TO BE OCCLUDED. BASED ON INFORMATION PROVIDED, THE PATIENT DID NOT EXPERIENCE ANY SIGNS AND SYMPTOMS, THE PATIENT CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150949 ↗
• InjuryNov 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED A HAKIM VALVE (ID (B)(4)) WAS IMPLANTED ON (B)(6) 2022. FIVE MONTHS AFTER IMPLANTATION THE PATIENT HAD FEVER AND HIGH INTRACRANIAL PRESSURE (ICP). THE VALVE WAS RETRIEVED ON (B)(6) 2022. IT IS UNKNOWN IF THE DEVICE HAS BEEN REPLACED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Fever

  MAUDE report 15878419 ↗
• InjuryAug 17, 2022Obstruction of Flow; Obstruction of Flow

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00377. A FACILITY REPORTED A HAKIM VALVE (ID 823832) AND BACTISEAL CATHETER (ID 823072) WERE IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022 THE PATIENT HAD HEADACHE AT VALVE IMPLANTATION SITE AND VENTRICULAR ENLARGEMENT. THE PATIENT HAS INCREASE WHITE BLOOD CELL WITHOUT FEVER. THE PHYSICIAN SUSPECTED INFECTION WITH OCCLUDED VALVE. ON (B)(6) 2022, THE PHYSICIAN REPLACED THE VALVE AND CATHETER. THE PATIENT WAS IN STABLE CONDITION AFTER THE REVISION. IT IS UNKNOWN IF THE PATIENT WAS UNDER ANTIBIOTICS.

  Patient problems: Cerebral Ventriculomegaly; Headache; Unspecified Infection

  MAUDE report 15240553 ↗
• InjuryAug 1, 2022Pressure Problem; Pressure Problem

  A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2022 WITH SETTING 100MMHG. AFTER A MONTH THE PATIENT DID NOT RECOVERED, THEN THE PHYSICIAN SET THE PRESSURE TO 70MMHG HOWEVER, HYDROCEPHALUS WAS NOT GETTING BETTER. THEN THE PHYSICIAN RESET THE PRESSURE TO 50MMHG, THE PATIENT STILL HAD HEADACHE. THE LUMBAR PUNCTURE FOR PRESSURE TESTING SHOWED THE ICP PRESSURE WAS 300MMHG. THE PHYSICIAN CONDUCTED A REVISION PROCEDURE AND REPLACED WITH A NEW HAKIM VALVE ON (B)(6) 2022 WHICH WAS SET AT 120MMHG. AFTER A WEEK PATIENT¿S SYMPTOM WAS RELIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15142108 ↗
• InjuryMay 19, 2022Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED IN A MALE PATIENT VIA V-P SHUNT ON (B)(6) 2014 WITH UNKNOWN SETTING DUE TO CEREBRAL AQUEDUCT STENOSIS. THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2021 AND IT WAS NOTED HIS DEMENTIA WORSENED. DUE TO SUSPICION OF UNDERDRAINAGE A SHUNT CONTRAST WAS PERFORMED, HOWEVER, THE FLOW COULD NOT BE CONFIRMED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. A WATER FLOW TEST WAS PERFORMED TO THE REMOVED VALVE AND THE DISTAL SIDE OF THE VALVE WAS OBSTRUCTED.

  Patient problems: Dementia

  MAUDE report 14438306 ↗
• InjuryApr 13, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A FACILITY REPORTED A HAKIM VALVE (ID 823832) WAS IMPLANTED ON (B)(6) 2022. THE VALVE WAS WITH PRESSURE 40 MMHG AND COULD NOT REACH THE EXPECTED PRESSURE SETTING 90MMHG. ON (B)(6) 2022, DURING THE EXPLORATORY SURGERY FOR SHUNT TUBE ADJUSTMENT, THE PHYSICIAN FOUND THAT THE VALVE HAS A CRACK AND A MINIMAL CSF LEAKING. THEREFORE, THE PHYSICIAN CHANGED WITH A NEW ID 823832 VALVE. THE PATIENT WAS STABLE AFTER THE REVISION PROCEDURE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14102746 ↗
• InjuryMar 29, 2022Break; Break

  A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED IN (B)(6) 2021. IN MID FEBRUARY, THE PATIENT WAS NOT FEELING GOOD AND ON (B)(6) 2022 A REVISION SURGERY WAS DONE. THE PHYSICIAN FOUND THAT THE JOINT PART BETWEEN THE VALVE AND THE ABDOMINAL CATHETER WAS BROKEN. THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED. ALL PARTS WERE RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 13942886 ↗
• InjuryMar 17, 2022Mechanical Problem; Mechanical Problem

  A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED VIA V-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2022 AND AN MRI EXAMINATION WAS PERFORMED. THE SET PRESSURE BEFORE MRI IMAGING WAS 200 MMH2O, BUT WHEN THE SET PRESSURE WAS CONFIRMED UNDER FLUOROSCOPY, THE PRESSURE CHANGED TO 30 MMH2O. THEREFORE, THE PRESSURE DID NOT CHANGE EVEN AFTER CHANGING THE PRESSURE AND CONFIRMING IT BY FLUOROSCOPY AGAIN. THE PRESSURE COULD NOT BE CHANGED EVEN WITH NEODYMIUM. THE VALVE WAS REMOVED AND REPLACED ON (B)(6), 2022.

  Patient problems: Failure of Implant

  MAUDE report 13792169 ↗
• InjuryMar 2, 2022Obstruction of Flow; Obstruction of Flow

  A FACILITY REPORTED A PATIENT WAS SENT TO HOSPITAL ON (B)(6), 2021 AFTER A CAR ACCIDENT. ON (B)(6), 2021, A HAKIM VALVE (ID 823832) AND A BACTISEAL CATHETER (ID 823072) WERE IMPLANTED DUE TO HYDROCEPHALUS. DURING A CT CHECK ON (B)(6) 2022, THE PHYSICIAN FOUND THAT THE HAKIM VALVE WAS OCCLUDED. THEN THEY CONDUCTED A REVISION PROCEDURE AND CHANGED WITH A NEW HAKIM VALVE (ID 823832). THE BACTISEAL CATHETER REMAINED IMPLANTED.

  Patient problems: Hydrocephalus

  MAUDE report 13652808 ↗
• InjuryJul 23, 2021Break; Break

  A FACILITY REPORTED HAKIM PROGRAMMABLE VALVE WAS IMPLANTED IN A PATIENT ON (B)(6) 2019, THE PATIENT RECOVERED WELL AFTER THE PROCEDURE. SEVERAL MONTHS AFTER THE PROCEDURE, THE PATIENT FELT NOT WELL, AND THE HAKIM VALVE WAS FOUND BROKEN THROUGH CT IMAGING. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2021 FOR A SHUNT REVISION PROCEDURE AND IMPLANTED WITH ANOTHER OF THE SAME VALVE, 823832.

  Patient problems: Failure of Implant

  MAUDE report 12216556 ↗
• InjuryJul 14, 2020Obstruction of Flow; Obstruction of Flow

  A POST-MARKET CLINICAL PROGRAM REPORTED VENTRICULOPERITONEAL SHUNT OBSTRUCTION: THE HAKIM VALVE WAS IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT RETURNED TO THE HOSPITAL AND THE PARENTS STATED THE PATIENT HAD BEEN CRYING FOR NEARLY 5 DAYS. THE PATIENT WAS DIAGNOSED WITH A VENTRICULOPERITONEAL SHUNT OBSTRUCTION AT THE VENTRICULAR END. ON (B)(6) 2018 THE PATIENT HAD A VENTRICULOSCOPY, CEREBROSPINAL FLUID DRAINAGE AND REMOVAL OF THE RIGHT VENTRICULOPERITONEAL SHUNT WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018 AND WAS NOTED TO BE HEALING WELL.

  Patient problems: Injury

  MAUDE report 10270238 ↗
• InjuryJul 31, 2018Obstruction of Flow; Obstruction of Flow

  AS REPORTED BY THE AFFILIATE, A HAKIM PROGRAMMABLE VALVE BECAME BLOCKED AFTER IMPLANTATION. ONE WEEK AFTER IMPLANT, THE VALVE WAS NOTED TO BE BLOCKED AND IT WAS REPLACED WITH ANOTHER. THERE IS NO REPORT OF FURTHER CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7736675 ↗