CODMAN® HAKIM® 823110 (REF 82-3110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780519133), received between Dec 6, 2022 and Apr 3, 2024 — classified as 5 injuries, 1 malfunction.

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

• InjuryApr 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A HAKIM VALVE (ID 823110) WAS IMPLANTED VIA VENTRICULAR PERITONEAL (VP) SHUNT IN (B)(6) 2023 FOR UNKNOWN REASON AND WITH UNKNOWN SETTING. IN (B)(6) 2024, THE DISTAL PART OF THE VALVE STARTED TO SWELL, AND LEAKAGE OF THE VALVE WAS CONFIRMED. THEREFORE, RE-OPERATION WAS PERFORMED. THE SHUNT WAS RE-CONNECTED TO THE VALVE. HOWEVER, IT STARTED TO SWELL AGAIN FROM BEGINNING OF (B)(6) 2024. THE PATIENT EXPERIENCED PAIN DUE TO SWELLING. THE PATIENT STATUS IS CURRENTLY ON FOLLOW-UP. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS A PLAN FOR REMOVING THE VALVE.

  Patient problems: Pain

  MAUDE report 19034241 ↗
• MalfunctionFeb 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  A FACILITY REPORTED THAT AFTER CONNECTING THE PERITONEAL AND VENTRAL CATHETERS OF A HAKIM VALVE (ID (B)(4)), THERE IS A LOW FLOW OF WATER IN THE CHAMBER PART. WHEN TESTING THE ACTUAL VALVE THE FAILURE WAS NOT SHOWING; HOWEVER, A MICRO-CHECK IS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONTACT OR INJURY WAS REPORTED; HOWEVER, THE EVENT LED TO 3 HOURS SURGICAL DELAY. THE VALVE WAS USED TO TREAT HYDROCEPHALUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416764 ↗
• InjuryFeb 21, 2023Output Problem; Output Problem

  N/A

  Patient problems: Insufficient Information

  MAUDE report 16409554 ↗
• InjuryDec 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  2 OF 2 REPORTS (SAME PATIENT, DIFFERENT VALVES). OTHER MFG REPORT NUMBER: 3013886523-2022-00579. A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2022 IN A 58 YEAR OLD MALE PATIENT. IT DID NOT FUNCTION PROPERLY AND WAS REPLACED ON (B)(6) 2022 WITH A NEW VALVE (ID 823110). THE SECOND VALVE PRESENTED WITH THE SAME FAILURE AND WAS EXPLANTED ON (B)(6) 2022. IT SEEMS THAT THERE WERE SOME DEBRIS IN THE VALVES. CONSEQUENCES FOR THE PATIENT: DROP IN CONSCIOUSNESS, LONGER HOSPITAL STAY. THE PATIENT STATUS IS: RECOVERED.

  Patient problems: Decreased Level of Consciousness

  MAUDE report 16022840 ↗
• InjuryDec 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  1 OF 2 REPORTS (SAME PATIENT, DIFFERENT VALVES). OTHER MFG REPORT NUMBER: 3013886523-2022-00580. A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED ON (B)(6) 2022 IN A 58 YEAR OLD MALE PATIENT. IT DID NOT FUNCTION PROPERLY AND WAS REPLACED ON (B)(6) 2022 WITH A NEW VALVE (ID 823110). THE SECOND VALVE PRESENTED WITH THE SAME FAILURE AND WAS EXPLANTED ON (B)(6) 2022. IT SEEMS THAT THERE WERE SOME DEBRIS IN THE VALVES. CONSEQUENCES FOR THE PATIENT: DROP IN CONSCIOUSNESS, LONGER HOSPITAL STAY. THE PATIENT STATUS IS: RECOVERED.

  Patient problems: Decreased Level of Consciousness

  MAUDE report 16022838 ↗
• InjuryDec 6, 2022Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  A FACILITY REPORTED A HAKIM VALVE (ID 823110) COULD NOT BE PROGRAMMED AND WAS EXPLANTED. THE VALVE WAS IMPLANTED ON (B)(6) 2022. WHEN THE MEDICAL STAFF TRIED TO PROGRAM THE VALVE AT HIGH PRESSURE LEVEL (180), THE VALVE DID NOT RESPOND. MEDICAL STAFF TRIED TO PROGRAM WITH ALL HAKIM PROGRAMMERS AVAILABLE IN THE HOSPITAL (3). NONE OF THEM SUCCEEDED. THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926138 ↗