CODMAN HAKIM RICKHAM 82-3113Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704041481), received between Jul 25, 2018 and Jan 11, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Unintended System Motion; Unintended System Motion

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823111) WAS IMPLANTED IN 2011 VIA VENTRICULOPERITONEAL (VP) SHUNT WITH UNKNOWN SETTING. THE PATIENT WAS SENT TO A HOSPITAL DUE TO BRAIN HEMORRHAGE. X-RAY SHOWS THAT "STEPPING MOTOR HAS FELL OFF AND MOVED TO THE PUMPING CHAMBER OF DISTAL PART OF THE VALVE". HOWEVER, CONSIDERING PATIENT'S AGE AND CONDITION, REVISION SURGERY WILL NOT BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491148 ↗
• InjuryOct 4, 2023Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823844) WAS IMPLANTED DUE TO SUBARACHNOID HEMORRHAGE VIA VENTRICULOPERITONEAL SHUNT ON (B)(6) 2013 WITH UNKNOWN SETTING. HOWEVER, SINCE 2017, THE VENTRICLES HAVE NOT SHRUNK. THE PATIENT SYMPTOMS DID NOT CHANGE, AND WAS FOLLOWED UP. AN OBSTRUCTION WAS SUSPECTED AND THE RESERVOIR WAS PUMPED, BUT NO ABNORMALITY WAS FOUND IN THE RESERVOIR. IN (B)(6) 2023, A COMPUTED TOMOGRAPHY SCAN REVEALED THAT THE PERITONEAL CATHETER HAD PROLAPSED, THEREFORE, THE VALVE WAS REMOVED ON (B)(6) 2023 BECAUSE THE PATIENT WAS ALSO SUFFERING FROM ABDOMINAL DISEASE. THE VALVE WAS NOT REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 17869026 ↗
• InjurySep 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819472 ↗
• InjuryAug 30, 2023Pressure Problem; Pressure Problem

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED VIA VENTRICULOPERITONEAL SHUNT IN (B)(6) 2008 WITH UNKNOWN SETTING. ON UNKNOWN DATE, THE PATIENT CAME TO THE HOSPITAL FOR A ROUTINE CHECK-UP. X-RAYS WERE PERFORMED AND VENTRICULAR ENLARGEMENT WAS OBSERVED. AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE WITH A POWERFUL MAGNET, BUT THE CHANGE WAS UNSUCCESSFUL. THE PATIENT HAD NO CLINICAL SYMPTOMS, BUT AS A PRECAUTION, A REVISION SURGERY WAS PERFORMED FOR FUTURE MANAGEMENT. THE VALVE WAS REMOVED AND REPLACED ON (B)(6), 2023. THE PATIENT RECOVERED.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 17650869 ↗
• InjurySep 14, 2022Output Problem; Output Problem

  A FACILITY REPORTED A HAKIM VALVE COULD NOT BE ADJUSTED: THE PATIENT HAS VENTRICULOPERITONEAL DERIVATION SINCE 1991. MRI EXAM OF SKULL WAS PERFORMED ON (B)(6) 2022 TO TREAT DIZZINESS AND HEADACHE WITH UNDETERMINED ORIGIN AFTER CT. AN X-RAY TO CONTROL/CHECK VALVE SETTING IS PERFORMED BEFORE AND AFTER THE EXAM ACCORDING TO INTERNAL (HOSPITAL) PROCESS. 15 X-RAYS EXAMS WERE PERFORMED TO ADJUST THE VALVE BY NEUROSURGEON. CONSEQUENCES FOR THE PATIENT: MULTIPLICATION OF X-RAYS AND CT SCANS FOR THE PATIENT BETWEEN APRIL AND JUNE 2022. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AS THE VALVE DID NOT FUNCTION.

  Patient problems: Dizziness; Headache

  MAUDE report 15419107 ↗
• InjuryAug 10, 2022Pressure Problem; Pressure Problem

  A PHYSICIAN REPORTED A MICRO VALVE WITH RICKHAM RESERVOIR AND UNITIZED DISTAL CATHETER (ID 823113) WAS IMPLANTED IN A FEMALE PATIENT VIA V-P SHUNT ON UNKNOWN DATE WITH 50 MMH2O. SINCE VENTRICULAR ENLARGEMENT WAS CONFIRMED ON (B)(6),2022, AN ATTEMPT WAS MADE TO CHANGE THE SET PRESSURE, BUT IT WAS NOT POSSIBLE. AFTER THAT, VENTRICULAR ENLARGEMENT DID NOT IMPROVED. DUE TO SUSPICION OF VALVE DAMAGED, THE VALVE WAS REMOVED AND REPLACED ON JULY 25, 2022.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 15198885 ↗
• InjuryMar 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED VIA V-P SHUNT ON (B)(6), 2021 WITH UNKNOWN SETTING. ON (B)(6), 2022, IMMEDIATELY AFTER THE MRI EXAMINATION, THE SET PRESSURE CHANGED AND IT BECAME IMPOSSIBLE TO RETURN THE SET PRESSURE TO THE ORIGINAL SETTING. WHEN VPV PROGRAMMER WAS USED, IT GOT AN ERROR MESSAGE AND THE SET PRESSURE WAS CHANGED IN A NARROW RANGE (APPROXIMATELY 120-160MMHG) UNDER FLUOROSCOPY. THE SET PRESSURE WAS SET TO 160MMHG, AND THE PATIENT'S CONDITION DID NOT CHANGE. THE PHYSICIAN DETERMINED THAT THE SHUNT WAS NO LONGER NEEDED AND THE VALVE WAS REMOVED ON (B)(6), 2022. THE PATIENT WAS RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 13871649 ↗
• MalfunctionDec 2, 2021Mechanical Jam; Mechanical Jam

  A FACILITY REPORTED A HAKIM VALVE BECAME STUCK OVER TIME. IT IS UNKNOWN WHETHER THIS IS AN ISSUE CAUSED BY THE VALVE ITSELF, OR BY OTHER FACTORS. THE PATIENT MAY NEED REVISION SURGERY TO REPLACE THE VALVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917616 ↗
• InjuryJul 25, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE HAKIM MICROVALVE COULD NOT BE PROGRAMMED AFTER MRI AND WAS REVISED. THE VALVE WAS IMPLANTED TO THE PATIENT VIA VP-SHUNT; HOWEVER, INITIAL SETTINGS ARE UNKNOWN. THE PRESSURE SETTING COULD NOT CHANGE AFTER MRI. THE REVISION SURGERY WAS PERFORMED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL REPORTED. THE PRODUCT WILL BE RETURNED TO YOUR SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718122 ↗