CODMAN HAKIM 82-3112Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704041474), received between Feb 3, 2022 and Jun 21, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED A HAKIM VALVE (ID (B)(4)) SEEMED TO BE CLOGGED. ATTEMPTS TO INTRAOPERATIVELY FLUSH THE SYSTEM FAILED, SYSTEM THUS WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758223 ↗
• InjuryJun 21, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  A FACILITY REPORTED A PRESSURE ISSUE OF A HAKIM VALVE (ID 823114). PATIENT BECAME SYMPTOMATIC DUE TO OVERDRAINAGE. THE VALVE WAS IMPLANTED IN OCTOBER 2018. THE VALVE WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 14758203 ↗
• InjuryMar 29, 2022Obstruction of Flow; Obstruction of Flow

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00120. A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A (B)(6) YEAR-OLD FEMALE PATIENT VIA V-P SHUNT ON (B)(6) 2020 WITH SETTING 4. ON AN UNKNOWN DATE, THE PRESSURE WAS SET TO SETTING 8. ON (B)(6) 2021, THE HAKIM VALVE WAS ADDED BY CONNECTING IT WITH A Y-SHAPED CONNECTOR. THE SETTING HAS NOT BEEN CHANGED SINCE THE INITIAL PRESSURE OF 30MMH2O. SUBCUTANEOUS RETENTION OCCURRED AND VALVE OBSTRUCTION WAS SUSPECTED, THE VALVES WERE REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13942878 ↗
• InjuryFeb 3, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED VIA V-P SHUNT IN 2014 WITH UNKNOWN SETTING. GAIT DISTURBANCE IMPROVED WITH 16 CM H2O. THE PATIENT WAS IN GOOD HEALTH FOR FOUR YEARS, BUT BECAME ILL AROUND 2018 AND BEGAN TO FALL REPEATEDLY AT THE END OF 2020. AFTER THAT, THE GAIT DISORDER PROGRESSED FURTHER. SINCE THE TENDENCY OF OVERDRAINAGE WAS CONFIRMED BY DIAGNOSTIC IMAGING, THE PHYSICIAN LOOKED AT THE SITUATION OF 200MM H2O. THE SITUATION DID NOT CHANGE, AND ENDOSCOPIC THIRD VENTRICULOSTOMY WAS PERFORMED ON (B)(6) 2022, AND THE VALVE WAS REMOVED. IMMEDIATELY BEFORE THE OPERATION, THE VENTRICULAR PRESSURE WAS MEASURED AGAIN, BUT THE PRESSURE WAS AS LOW AS 200 MMH2O. IT IS UNKNOWN IF THE VALVE WAS REPLACED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13444665 ↗