CODMAN® HAKIM® 823113 (REF 82-3113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10381780519164), received between Aug 11, 2022 and Mar 4, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025No Flow; No Flow

  A PHYSICIAN REPORTED: A PATIENT OF UNSPECIFIED AGE AND GENDER WHO HAD SHUNT MALFUNCTION DURING THE USE OF CHPV SHUNT (ID 823113) FOR AN UNREPORTED INDICATION. NOT REPORTED: PRODUCT LOT NUMBER, PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION, FAMILY HISTORY, DRUG ALLERGIES, PAST MEDICATION, CONCOMITANT MEDICATION AND CO-SUSPECT MEDICATIONS. ON AN UNKNOWN DATE, CHPV SHUNT WAS NOT WORKING ON OT (OPERATING TABLE) TABLE, AND THE HOSPITAL RETURNED THE PRODUCT. AT THE TIME OF THE REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. PHYSICIAN COMMENTS: "THIS CASE WAS ASSESSED AS SERIOUS DUE TO OTHER MEDICALLY IMPORTANT CONDITION." AS REPORTED: "THIS IS A SERIOUS CASE REGARDING A PATIENT OF UNSPECIFIED AGE AND GENDER WHO HAD SHUNT MALFUNCTION DURING THE USE OF CHPV SHUNT (CODMAN HAKIM PROGRAMMABLE VALVE) MEDICAL DEVICE FOR AN UNREPORTED INDICATION. THE CAUSALITY WITH RESPECT TO THE SUSPECT DRUG WAS CONSIDERED NOT ASSESSABLE FOR SHUNT MALFUNCTION BASED ON THE NATURE OF THE EVENT, AND OWING TO LACK OF INFORMATION REGARDING PATIENT'S IDENTIFIERS (AGE, GENDER, ETHNICITY), THERAPY INDICATION, EVENT ONSET DATE, ANY ADVERSE CLINICAL EVENT DUE TO DEVICE MALFUNCTION, CONCURRENT MEDICAL CONDITION, CO-SUS

  Patient problems: Insufficient Information

  MAUDE report 21515009 ↗
• InjuryFeb 14, 2025Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS A PRETERM BABY BY LSCS (LOWER SEGMENT CAESAREAN SECTION). ON DAY 2 OF LIFE, NEUROSONOGRAM SHOWED POST GERMINAL MATRIX HEMORRHAGE WITH IVH (INTRAVENTRICULAR HEMORRHAGE, MENINGITIS, NEONATAL SEPSIS. THE PATIENT WAS BROUGHT TO HOSPITAL WITH HISTORY OF INCREASED HEAD CIRCUMFERENCE SINCE 2-1/2 MONTHS, INSIDIOUS ONSET, GRADUALLY PROGRESSIVE, COMPLAINING OF IRRITABILITY AND CRYING SINCE 2-1/2 MONTHS WHILE HAVING FEEDS AND COMPLAINING OF RIGHT-SIDE POSTURING OR BABY WHILE CRYING FOR DURATION OF AROUND 10 SECONDS NOT ASSOCIATED WITH ANY JERKY MOVEMENTS, UP ROLLING OF EYES. NO DRUG ALLERGIES AND FOOD ALLERGIES WERE REPORTED. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED, AND HIS VITALS WERE STABLE AND PHYSICAL EXAMINATION SHOWED NO PALLOR / ICTERUS / CYANOSIS/LYMPHADENOPATHY / OEDEMA WAS OBSERVED. SYSTEMIC EXAMINATION OF CNS SHOWED CONSCIOUS, ACTIVE, ALERT, IRRITABLE, MOVING ALL 4 LIMBS. SUN SETTING SIGN +, ENGORGED SCALP VEINS +0 AF TENSE. HEAD CIRCUMFERENCE 38 CM. NO SOCIAL SMILE. NO NECK CONTRACTION. THE PATIENT WAS DIAGNOSED WITH COMMUNICATING HYDROCEPHALUS AND WAS STARTED TREATMENT FOR CONGENITAL HYDROCEPHALUS, DEVELOPMENTAL DELAY. ON (B)(6) 2023, THE PATIENT HAD PROCEDUR

  Patient problems: Hydrocephalus; Swelling/ Edema

  MAUDE report 21387629 ↗
• InjuryDec 13, 2024Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 20926213 ↗
• InjuryNov 5, 2024Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  A FACILITY REPORTED HEAD SWELLING AT THE PART OF BURR OF A HAKIM VALVE (UNKNOWN ID). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Swelling/ Edema

  MAUDE report 20615610 ↗
• InjuryDec 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: Blurred Vision; Intracranial Hemorrhage; Memory Loss/Impairment; Pain

  MAUDE report 18302511 ↗
• InjuryNov 28, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED ON (B)(6) 2022. THE PATIENT CAME IN WITH SHUNT OVER DRAINAGE. MEDICAL STAFF NEEDED TO SET THE VALVE PRESSURE, HOWEVER, THEY WERE UNABLE TO REPROGRAM THE VALVE AFTER MULTIPLE ATTEMPTS AND A VALVE REVISION WAS REQUIRED. OPERATION PERFORMED; "ENDOSCOPIC SEPTOSTOMY AND LEFT FRONTAL KOCHER'S POINT PROGRAMMABLE VP SHUNT UNDER GA."

  Patient problems: Insufficient Information

  MAUDE report 15869393 ↗
• InjurySep 13, 2022Output Problem; Output Problem

  A FACILITY REPORTED A HAKIM VALVE (ID 823113) WAS IMPLANTED ON (B)(6) 2021 FOR A CEREBROSPINAL FLUID DIVERSION. THE NEUROSURGEON WAS UNABLE TO REPROGRAM THE SHUNT. THEREFORE, IT WAS REMOVED AND REPLACED ON (B)(6), 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412546 ↗
• MalfunctionAug 11, 2022Contamination; Contamination

  A FACILITY REPORTED A MICRO VALVE WITH RICKHAM RESERVOIR AND UNITIZED DISTAL CATHETER (ID 82311) HAD A FOREIGN OBJECT INSIDE. IT WAS FOUND WHEN THEY OPENED THE PRODUCT BEFORE USING IT IN THE PATIENT. NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211116 ↗