CODMAN HAKIM 82-3148Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704041542), received between Mar 2, 2023 and Mar 24, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2024Pressure Problem; Pressure Problem

  A PHYSICIAN REPORTED A SHUNT MALFUNCTIONING ON A HAKIM VALVE (ID 823148) AFTER DOING MAGNETIC RESONANCE IMAGING (MRI). A 80 YEAR-OLD MALE PATIENT WITH A CASE OF NORMAL PRESSURE HYDROCEPHALUS FOR WHICH PROGRAMMABLE VENTRICULOPERITONEAL (VP) SHUNT WAS DONE IN (B)(6) 2018. THE PATIENT WAS DOING ALRIGHT BUT READMITTED IN THE HOSPITAL IN (B)(6) 2023 FOR A SUSPECTED ISCHEMIC STROKE. A MAGNETIC RESONANCE IMAGING (MRI) BRAIN (PAIN) WAS PERFORMED 1.5 T MACHINE. THE SHUNT VALVE OPENING PRESSURE WAS KEPT DURING SURGERY AT 120MM H20, AND A PATIENT WAS DISCHARGED AFTER IT WAS RESET TO 120 MM H20. ON (B)(6) 2023, HE WAS ADMITTED AGAIN WITH BILATERAL MASSIVE SUBDURAL HEMORRHAGE FOR WHICH EMERGENCY SURGERY WAS DONE TO EVACUATE THE BLOOD IN THE ODD HOUR. IT WAS PRESUMED THAT THERE WAS OVERDRAINAGE OF CEREBROSPINAL FLUID (CSF), THEREFORE SHUNT TUBE WAS TIED AT THE CHEST WALL SO THAT NO CEREBROSPINAL FLUID (CSF) CAN FLOW SINCE NO TECHNICIAN WAS AVAILABLE TO RESET THE SHUNT. A PATIENT IMPROVED LATER AND WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6), 2024, HE WAS ADMITTED AGAIN WITH DROWSINESS AND A COMPUTED TOMOGRAPHY (CT) BRAIN SHOWED VENTRICULOMEGALY. AN X-RAY PERFORMED TO SEE THE VALVE OPENING PRESSU

  Patient problems: Cerebral Ventriculomegaly; Intracranial Hemorrhage

  MAUDE report 18966522 ↗
• InjuryJan 17, 2024Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823148) WAS IMPLANTED IN A PATIENT WITH COMMUNICATING HYDROCEPHALUS VIA LUMBOPERITONEAL (LP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED OBSTRUCTION OF THE VALVE. THE VALVE AND VENTRICULAR CATHETER WERE EXPLANTED AND REPLACED ON (B)(6) 2023. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE VENTRICULAR CATHETER IS A COMPONENT OF THE HAKIM VALVE.

  Patient problems: Insufficient Information

  MAUDE report 18530289 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED A HAKIM VALVE (ID 823148) WAS IMPLANTED IN (B)(6) 2022 FOR MANAGEMENT OF CEREBROSPINAL FLUID RETENTION. THE PATIENT WAS ADMITTED IN EMERGENCY ROOM ON (B)(6) 2023 WITH DIAGNOSIS OF RIGHT CEREBELLOPONTINE ANGLE TUMOR WITH HYDROCEPHALUS, STATUS POST LEFT VENTRICULAR-PERITONEAL (VP) SHUNT INSERTION WITH SHUNT MALFUNCTION. THE PRESSURE SETTING WAS SET MANY TIMES BUT THERE WAS NO RESPONSE. THE VALVE WAS REMOVED ON UNKNOWN DATE, HOWEVER, THERE IS NO INFORMATION IF THE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 16469989 ↗