CODMAN MEDOS 82-3045Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704041276), received between Jul 31, 2018 and Sep 6, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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.

• InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Erythema; Local Reaction; Rash

  MAUDE report 17691242 ↗
• InjuryJan 25, 2023Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 16241584 ↗
• InjurySep 22, 2022Activation, Positioning or Separation Problem; Infusion or Flow Problem; Activation, Positioning or Separation Problem; Infusion or Flow Problem

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00437 A PHYSICIAN REPORTED A CERTAS VALVE (ID 8228814) WAS IMPLANTED DUE TO SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) VIA VP SHUNT ON (B)(6) 2022 WITH SETTING 5. IT WAS USED WITH HAKIM PERITON CATH (ID 823045). ON (B)(6) 2022, PATIENT HYDROCEPHALUS WORSENED. THE SET PRESSURE OF THE VALVE COULD NOT BE CHANGED. A CEREBROSPINAL FLUID TEST SHOWED A HIGH PROTEIN CONCENTRATION OF 173 MG/DL. THE PHYSICIAN TRIED TO PASS WATER THROUGH THE PERITONEAL CATHETER DURING THE SURGERY AND THE FLOW WAS POOR. THEREFORE, THE VALVE AND THE PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Hydrocephalus

  MAUDE report 15464942 ↗
• InjuryJun 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00295, 3013886523-2022-00296. A PHYSICIAN REPORTED A CERTAS VALVE (828804) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2017 WITH UNKNOWN SETTING DUE TO SAH (SUBARACHNOID HEMORRHAGE). THE VALVE WAS IMPLANTED WITH LONG HAKIM VENTRICULAR CATHETER (ID NS9001) AND HAKIM PERITON CATHETER. AN UNKNOWN FAILURE WAS SUSPECTED; THEREFORE, THE VALVE AND CATHETERS WERE REMOVED AND REPLACED ON (B)(6) 2020. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852820 ↗
• InjuryJun 8, 2022Obstruction of Flow; Obstruction of Flow

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00248, 3013886523-2022-00249. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED VIA L-P SHUNT IN (B)(6) 2017 WITH UNKNOWN SETTING. IT WAS USED WITH HAKIM PERITONEAL CATHETER (823045) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). AN OBSTRUCTION WAS SUSPECTED, HOWEVER, ONLY THE PERITONEAL CATHETER(823045) WAS REMOVED AND REPLACED ON (B)(6) 2018. DUE TO SUSPICION OF OBSTRUCTION THE VALVE AND THE HAKIM PERITONEAL CATHETER (823045) WERE REMOVED AND REPLACED ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632134 ↗
• InjuryJun 8, 2022Obstruction of Flow; Obstruction of Flow

  THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00249, 3013886523-2022-00250. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED VIA L-P SHUNT IN (B)(6) 2017 WITH UNKNOWN SETTING. IT WAS USED WITH HAKIM PERITONEAL CATHETER (ID 823045) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). AN OBSTRUCTION WAS SUSPECTED, HOWEVER, ONLY THE HAKIM PERITONEAL CATHETER (ID 823045) WAS REMOVED AND REPLACED ON (B)(6) 2018. DUE TO SUSPICION OF OBSTRUCTION THE VALVE AND THE HAKIM PERITONEAL CATHETER (ID 823045) WERE REMOVED AND REPLACED ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631897 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00171. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. THE PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED IN A (B)(6) FEMALE PATIENT VIA "L-P SHUNT" ON (B)(6) 2021 WITH SETTING 5. THE VALVE WAS USED WITH A 823045 (SERIAL: UNK) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). ON (B)(6) 2021 THE PATIENT COMPLAINED OF HEADACHE, THE SET PRESSURE OF THE VALVE WAS CHANGED TO SETTING 7 AND SYMPTOM IMPROVED. ON (B)(6) 2022 , THE PATIENT HAD A GAIT DISORDER AND SET PRESSURE WAS CHANGED TO SETTING 2. THE PATIENT'S SYMPTOMS DID NOT IMPROVE AND VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VALVE, PERITONEAL CATHETER (823045) AND THE SILASCON LUMBAR CATHETER WERE REMOVED ON (B)(6) 2022. A RUPTURE OF THE LUMBAR CATHETER WAS CONFIRMED AT THE TIME OF REMOVAL. THE VALVE WAS REPLACED VIA "V-P SHUNT" ON (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties; Cerebral Ventriculomegaly; Headache

  MAUDE report 14159924 ↗
• InjuryJul 31, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MEDOS PERITONEAL CATHETER WAS LEAKING POST IMPLANTATION AND THERE WAS REVISION OF THE DEVICE. THE VALVE WAS IMPLANTED TO THE PATIENT VIA L-P SHUNT, DATE OF IMPLANT AND INITIAL SETTING ARE UNKNOWN. AT THE OUTPATIENT DEPARTMENT, THE PATIENT COMPLAINED OF FEELING SICK. LEAKAGE OF CSF WAS CONFIRMED AT 1 CM FROM THE DISTAL CONNECTION ON THE CATHETER BY AN IMAGE. THE REVISION SURGERY WAS PERFORMED, AND CRACKED PART OF THE CATHETER WAS CUT OFF AND THEN THE CATHETER WAS RE-CONNECTED. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL. THE PRODUCT WILL NOT BE RETURNED TO YOUR SITE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7736568 ↗