CODMAN HAKIM 82-3164Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704041566), received between Jun 14, 2022 and Aug 27, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Pressure Problem; Pressure Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 20080588 ↗
• InjuryAug 15, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  N/A

  Patient problems: Insufficient Information

  MAUDE report 17551003 ↗
• InjuryAug 2, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00359. A PHYSICIAN REPORTED A HAKIM PROGRAMMABLE VALVE WAS IMPLANTED IN A 15 YEAR-OLD MALE PATIENT TO TREAT AQUEDUCTAL STENOSIS WITH HYDROCEPHALUS BUT LATER DEVELOPED BILATERAL SUBDURAL COLLECTIONS. THE SUBDURAL COLLECTIONS WERE EVACUATED, SHUNT WAS REVISED AND CHANGED TO A PROGRAMMABLE VP SHUNT WITH PRESSURE AT 70MMH2O ON (B)(6) 2022. THEN PATIENT DEVELOPED RECURRENCE OF BILATERAL SUBDURAL COLLECTION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE HE UNDERWENT ON A RE- EVACUATION OF SUBDURAL HEMATOMA ON (B)(6) 2022 AND PRESSURE SETTING WAS INCREASED TO 110MM. HE UNDERWENT A REPEAT CT IMAGING THAT SHOWED NO SIGNIFICANT INCREMENT IN VENTRICLE SIZE AND HENCE PRESSURE SETTING WERE AGAINST CHANGED TO 140 AND LATER TO 200. HE ALSO UNDERWENT REPEAT EVACUATION OF BILATERAL SUBDURAL HEMATOMA ON (B)(6) 2022 BECAUSE OF SHUNT OVER DRAINAGE. REPEAT IMAGING ARE SUGGESTIVE THAT THE PRESSURE CHANGES IN THE SHUNT ARE NOT WORKING AND HENCE SHUNT WAS LIGATED ON (B)(6) 2022 THE VALVE WAS REMOVED.

  Patient problems: Hematoma

  MAUDE report 15148288 ↗
• InjuryAug 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00358. A PHYSICIAN REPORTED A HAKIM PROGRAMMABLE VALVE WAS IMPLANTED IN A 15 YEAR-OLD MALE PATIENT TO TREAT AQUEDUCTAL STENOSIS WITH HYDROCEPHALUS BUT LATER DEVELOPED BILATERAL SUBDURAL COLLECTIONS. THE SUBDURAL COLLECTIONS WERE EVACUATED, SHUNT WAS REVISED AND CHANGED TO A PROGRAMMABLE VP SHUNT WITH PRESSURE AT 70MMH2O ON (B)(6) 2022. THEN PATIENT DEVELOPED RECURRENCE OF BILATERAL SUBDURAL COLLECTION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE HE UNDERWENT ON A RE- EVACUATION OF SUBDURAL HEMATOMA ON (B)(6) 2022 AND PRESSURE SETTING WAS INCREASED TO 110MM. HE UNDERWENT A REPEAT CT IMAGING THAT SHOWED NO SIGNIFICANT INCREMENT IN VENTRICLE SIZE AND HENCE PRESSURE SETTING WERE AGAINST CHANGED TO 140 AND LATER TO 200. HE ALSO UNDERWENT REPEAT EVACUATION OF BILATERAL SUBDURAL HEMATOMA ON (B)(6) 2022 BECAUSE OF SHUNT OVER DRAINAGE. REPEAT IMAGING ARE SUGGESTIVE THAT THE PRESSURE CHANGES IN THE SHUNT ARE NOT WORKING AND HENCE SHUNT WAS LIGATED ON (B)(6) 2022 AND ON (B)(6) 2022 THE VALVE WAS REMOVED.

  Patient problems: Hematoma

  MAUDE report 15148287 ↗
• InjuryJul 6, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED A HAKIM VALVE (823164) WAS IMPLANTED IN A PEDIATRIC MALE PATIENT VIA V-P SHUNT ON (B)(6) 2022 WITH 200MMH2O. ON JUNE 14, 2022 THE PATIENT WAS VOMITING AND UNDERDRAINAGE WAS SUSPECTED. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Vomiting

  MAUDE report 14934678 ↗
• InjuryJun 14, 2022Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A HAKIM PROGRAMMABLE VALVE (823164) WAS IMPLANTED VIA V-P SHUNT WITH UNKNOWN SETTING. OBSTRUCTION WAS SUSPECTED THUS THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. THE PATIENT IS NOW FOLLOWING UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687912 ↗