CODMAN HAKIM 82-3114Recalls & reported problems
Cerenovus, Inc. · CODMAN HAKIM Programmable Valve Micro Valve 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, Straight Connector(s), Right Angle Adapter and Priming Adapter · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704041498), received between Feb 15, 2022 and May 28, 2025 — classified as 7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Infusion or Flow Problem1
- Insufficient Device Problem Information1
- No Flow1
- Pressure Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Failure of Implant1
- Fatigue1
- Hydrocephalus1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
- Vomiting1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025No Flow; No Flow
InjuryMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJul 19, 2023Infusion or Flow Problem; Infusion or Flow Problem
A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED IN 2017 TO TREAT HYDROCEPHALUS. IN (B)(6)2023 PATIENT PRESENTED WITH WALKING DIFFICULTIES, NO SIGN OF INTRACRANIAL HYPERTENSION. MRI SHOW SIGN OF OVER-DRAINAGE. X RAY SHOW THAT MAIN BODY PART OF VALVE COULD NOT BE SET UP. A REVISION SURGERY WAS NEEDED TO REPLACE THE MAIN BODY OF THE VALVE. PATIENT RECOVERING.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 17350243 ↗InjuryAug 15, 2022Break; Break
A FACILITY REPORTED THAT DURING X-RAYS CONTROL ON (B)(6) 2022, THE HAKIM VALVE SEEMED TO BE BROKEN AND WAS REMOVED ON (B)(6) 2022. THE VALVE WAS INITIALLY IMPLANTED IN 2009.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15228081 ↗InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPORTED A HAKIM VALVE (ID 823114) STOPPED WORKING DURING SURGERY AND IT WAS REPLACED. THE EVENT LED TO 1 HOUR SURGICAL DELAY. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 14685085 ↗InjuryApr 5, 2022Pressure Problem; Pressure Problem
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2019 WITH UNKNOWN SETTING FOR THE TREATMENT OF EPILEPSY. ON JUNE 25, 2019, THE SET PRESSURE WAS CHANGED TO 50 MMH2O. IN 2020, THE PHYSICIAN TRIED TO CHANGE THE SET PRESSURE USING NEODYMIUM, BUT COULD NOT CHANGE. IT IS UNKNOWN IF THE PATIENT- EXPERIENCED ANY SIGNS AND SYMPTOMS. THEN IT WAS TRIED TO CHANGE THE SET PRESSURE ON (B)(6) 2022 USING THE NEODYMIUM HOWEVER, THE SET PRESSURE COULD NOT BE CHANGE. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON THE SAME DAY,
Patient problems: Insufficient Information
MAUDE report 14015394 ↗InjuryFeb 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED WITH SETTING 130MMHG ON (B)(6) 2015. THE VALVE SETTING CHANGED TO 80MMHG AND SEVERAL ATTEMPTS WERE DONE TO READJUST IT ((B)(6)AND (B)(6) 2022) WITHOUT SUCCESS. THE PATIENT HAD VOMITING AND MARKED ASTHENIA. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE VALVE AND SYMPTOMS IMPROVED.
Patient problems: Fatigue; Vomiting
MAUDE report 13536553 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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