CODMAN HAKIM 82-3184Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704041580), received between Jul 25, 2018 and Aug 14, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Hydrocephalus

  MAUDE report 22809217 ↗
• InjuryAug 2, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A PHYSICIAN REPORTED AN 80-YEAR-OLD MALE PATIENT WHO HAD SHUNT MALFUNCTION, URINARY INCONTINENCE, CEREBROSPINAL FLUID RETENTION, MOVEMENT DISORDER, SLEEP EXCESSIVE, MEMORY DEFICIT DURING THE USE OF HAKIM VALVE (ID (B)(6)) FOR NORMAL PRESSURE HYDROCEPHALUS INDICATION. NOT REPORTED: PATIENT MEDICAL HISTORY, FAMILY HISTORY, PAST MEDICATION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION AND RELEVANT LAB DATA. ON (B)(6) 2024, THE PATIENT WAS PLACED WITH HAKIM VALVE. ON AN UNKNOWN DATE, PATIENT DEVELOPED SYMPTOMS SUCH AS URINARY INCONTINENCE, INCREASED SLEEPINESS (HYPERSOMNIA) AND MEMORY DEFICIT (MEMORY IMPAIRMENT). THE PHYSICIAN ADVISED REDUCING THE VALVE PRESSURE TO 130 MM. IT WAS ATTEMPTED TO REPROGRAM THE VALVE FROM 150 MM TO 130 MM, BUT THE VALVE GOT STUCK AT 50/60/70 MM LEVELS. ON (B)(6) 2024 AND (B)(6) 2024, THE PHYSICIAN TRIED MULTIPLE ATTEMPTS TO PROGRAM IT, EVEN PLACING THE PROGRAMMING DEVICE AT DIFFERENT ANGLES, IT DID NOT HELP. PHYSICIAN TRIED TO PROGRAM THE UNOPENED DEVICE AND IT WORKED. SO, IT WAS CONCLUDED MALFUNCTIONING OF THE VALVE. THIS CAUSED COLLECTION OF FLUID BETWEEN THE BRAIN AND SKULL (CEREBROSPINAL FLUID RETENTION). LIMB MOVEMENTS ARE AFFECTED ON THE LEFT SIDE (M

  Patient problems: Memory Loss/Impairment; Sleep Dysfunction; Urinary Incontinence

  MAUDE report 19893077 ↗
• MalfunctionJul 30, 2018Mechanical Problem; Mechanical Problem

  AS REPORTED BY THE OUS AFFILIATE, A HAKIM PROGRAMMABLE VALVE COULD NOT BE REPROGRAMMED AND WAS REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731623 ↗
• InjuryJul 25, 2018Obstruction of Flow; Obstruction of Flow

  AS REPORTED BY THE AFFILIATE, A HAKIM PROGRAMMABLE VALVE BECAME BLOCKED AND WAS EXPLANTED. ANOTHER HAKIM WAS USED TO REPLACE.

  Patient problems: Missing Value Reason

  MAUDE report 7719554 ↗
• InjuryJul 25, 2018Mechanical Problem; Mechanical Problem

  AS REPORTED BY THE OUS AFFILIATE,THE HAKIM RIGHT ANGLE PROGRAMMABLE VALVE HAD UNEXPECTED SETTING CHANGES AFTER IMPLANTATION. IN (B)(6) 2018 THE VALVE WAS PROGRAMMED TO 70 AND LATER, THE VALVE WAS CONFIRMED AT 30 VIA X-RAY, THEN IN (B)(6) 2018 THE VALVE WAS SET TO 70 AND LATER CONFIRMED TO BE AT 50 VIA X-RAY. THE VALVE WAS AGAIN REPROGRAMMED TO 70; HOWEVER, FOR A THIRD TIME, IT WAS DISCOVERED AT A DIFFERENT SETTING, 30 CONFIRMED VIA X-RAY. THERE IS NO REPORT OF DEVICE REVISION. IT WAS ALSO REPORTED THAT THE PATIENT HAS NOT UNDERGONE ANY FRESH MRI OR TRAVEL ANYWHERE FLIGHT OR INVOLVE ANY ACTIVITY THAT CAN HAMPER THE SETTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7719420 ↗