CODMAN BACTISEAL 82-3073Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704041320), received between Jun 29, 2022 and Jun 6, 2025 — classified as 4 injuries.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00125. 3013886523-2025-00127. EVENT FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A HAKIM VALVE (ID 823832), A VENTRICULAR BACTISEAL CATHETER (ID 823073) AND A PERITONEAL BACTISEAL CATHETER (ID 823074) WERE IMPLANTED ON (B)(6) 2020. THE PATIENT WAS ADMITTED TO THE PEDIATRIC IMMUNOLOGY AND NEPHROLOGY DEPARTMENT FOR TREATMENT ON (B)(6) 2020. THE CHIEF COMPLAINT WAS INTERMITTENT FEVER AND COUGH MORE THAN HALF A MONTH. AFTER TREATMENT, THE CHILD'S FEVER GRADUALLY IMPROVED, BUT THE SUBCUTANEOUS EFFUSION IN THE OCCIPITAL REGION DID NOT IMPROVE. THEREFORE, ON (B)(6) 2020, AN EXPLORATION AND ADJUSTMENT OF THE OCCIPITAL CISTERN SHUNT TUBE WAS PERFORMED. THE OPERATION WENT SMOOTHLY. AFTER THE OPERATION, LOCAL COMPRESSION BANDAGING WAS GIVEN, AND THE CHILD RECOVERED SMOOTHLY AND WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2020, THE PATIENT HAD RECURRENT FEVER, AND ON (B)(6) 2020, THE 0MNAY SAC WAS IMPLANTED AND THE VENTRICLE WAS PERFORMED UNDER GENERAL ANESTHESIA. THE ABDOMINAL SHUNT TUBE REMOVAL SURGERY WENT SMOOTHLY. ANTI-INFECTION, ANTI-INFLAMMATORY AND ANTIFEVER TREATMENT, AS WELL AS FLUID REPLACEMENT THERAPY

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22158993 ↗
• InjuryAug 9, 2023Obstruction of Flow; Obstruction of Flow

  N/A

  Patient problems: Brain Injury; Convulsion/Seizure; Headache

  MAUDE report 17489325 ↗
• InjuryNov 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00533 AND 3013886523-2022-00535. A FACILITY REPORTED A CERTAS VALVE (ID 828814) WAS IMPLANTED VIA V-P SHUNT ON NOVEMBER 2021 WITH UNKNOWN SETTING. IT WAS USED WITH A BACTISEAL VENTRICULAR CATHETER (ID 823073 SERIAL: UNK) AND A BACTISEAL PERITONEAL CATHETER (ID 823074 SERIAL: UNK). IN THE BEGINNING OF (B)(6) THE SKIN AT THE SITE WHERE THE VALVE WAS PLACED WAS THINNING, AND A FISTULA OF ABOUT 2 MM WAS FORMED, THROUGH WHICH CEREBROSPINAL FLUID LEAKED. ON (B)(6) 2022 WHEN THE VALVE WAS REMOVED, DAMAGE TO THE SILICONE NEAR THE SG WAS CONFIRMED. THE BACTISEAL VENTRICULAR CATHETER AND THE BACTISEAL PERITONEAL CATHETER WERE ALSO REMOVED ON (B)(6) 2022. AFTER SHUNT REMOVAL, THERE IS A TENDENCY FOR VENTRICULAR ENLARGEMENT. THE VALVE WAS NOT REPLACED.

  Patient problems: Cerebrospinal Fluid Leakage; Fistula

  MAUDE report 15749893 ↗
• InjuryJun 29, 2022Disconnection; Disconnection

  A PHYSICIAN REPORTED A BACTISEAL VENTRICULAR CATHETER (ID 823073) WHICH WAS CONNECTED TO A HAKIM VALVE (ID 823162) HAD DISCONNECTED ON (B)(6) 2022 AFTER VP SHUNT. IT IS UNKNOWN HOW THE ISSUE WAS FOUND. ALL PARTS OF CATHETER WERE RETRIEVED. THE CATHETER WAS REPLACED AND NO HEALTH HAZARD WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852317 ↗