CODMAN BACTISEAL 82-3074Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704041337), received between Apr 5, 2022 and Jun 6, 2025 — classified as 12 injuries.

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

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

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

  THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS:3013886523-2025-001253013886523-2025-00126EVENT 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 W

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22159002 ↗
• InjuryMay 2, 2024Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 19234556 ↗
• InjuryJul 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Confusion/ Disorientation; Headache; Vomiting

  MAUDE report 17395977 ↗
• InjuryJan 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  OTHER MFG REPORT NUMBER: 3013886523-2023-00019. A FACILITY REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED IN A 75 YEAR-OLD MALE PATIENT DUE TO SAH (SUBARACHNOID HEMORRHAGE) VIA L-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. IT WAS USED WITH 823074 (SERIAL;UNK). AFTERWARDS, IMAGING WAS PERFORMED AND CEREBROSPINAL FLUID RETENTION WAS CONFIRMED AROUND THE STEPPED CONNECTOR PROXIMAL TO THE VALVE. THE VALVE AND THE PERITONEAL CATHETER (ID 823074) WERE REMOVED AND REPLACED ON (B)(6) 2023.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16263770 ↗
• InjuryNov 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00533, 3013886523-2022-00534. A FACILITY REPORTED A CERTAS VALVE (ID 828814) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2021 WITH UNKNOWN SETTING. IT WAS USED WITH A BACTISEAL VENTRICULAR CATHETER (ID 823073 SERIAL;UNK) AND A BACTISEAL PERITONEAL CATHETER (ID 823074SERIAL;UNK). IN THE BEGINNING OF OCTOBER, 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 15749891 ↗
• InjuryNov 7, 2022Disconnection; Disconnection

  A FACILITY REPORTED A BACTISEAL PERITONEAL CATHETER (ID 823074) AND A BACTISEAL VENTRICULAR CATHETER (ID 823073 SERIAL;UNK) WERE IMPLANTED WITH A CERTAS VALVE (828814) VIA V-P SHUNT ON NOVEMBER 2021 WITH UNKNOWN SETTING. IN (B)(6) 2022, SINCE THE PERITONEAL CATHETER WAS DISCONNECTED, ONLY THE PERITONEAL CATHETER WAS REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 15749890 ↗
• InjurySep 8, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00412. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED VIA L-P SHUNT ON (B)(6) 2022, WITH SETTING 3. IT WAS USED WITH BACTISEAL PERITONEAL CATHETER (ID 823074). AFTER 1 WEEK OF IMPLANTATION, THE PATIENT HAD A TENDENCY FOR VENTRICULOMEGALY AND PRESENTED WITH DISORIENTATION. AN MRI WAS PERFORMED, AND THE FLOW COULD NOT BE CONFIRMED ON THE VENTRAL SIDE. THE VALVE AND THE PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022. PATIENT RECOVERY WAS OBSERVED.

  Patient problems: Cerebral Ventriculomegaly; Confusion/ Disorientation

  MAUDE report 15379312 ↗
• InjuryJun 10, 2022Obstruction of Flow; Obstruction of Flow

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00260. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804 ) WAS IMPLANTED DUE TO SAH (SUBARACHNOID HEMORRHAGE) VIA V-P SHUNT ON (B)(6) 2020 WITH UNKNOWN SETTING. IT WAS USED WITH PERITONEAL CATHETER 823045. SINCE OBSTRUCTION WAS SUSPECTED, THE VALVE AND THE PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 14655343 ↗
• InjuryJun 1, 2022Obstruction of Flow; Obstruction of Flow

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00238. A PHYSICIAN REPORTED A CERTAS VALVE (828804) WAS IMPLANTED IN A (B)(6)-YEAR OLD FEMALE PATIENT VIA L-P SHUNT ON (B)(6) 2022 WITH UNKNOWN SETTING. IT WAS USED WITH BACTISEAL CATHETER (ID 823074) (SERIAL;UNK) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). ON (B)(6) 2022 AN MRI EXAMINATION WAS PERFORMED AND VENTRICULAR ENLARGEMENT WAS CONFIRMED. AN ATTEMPT WAS MADE TO CHANGE THE PRESSURE, HOWEVER, IT WAS NOT POSSIBLE. THE PATIENT HAD NO CLINICAL SYMPTOMS. ON (B)(6) 2022 VENTRICULAR ENLARGEMENT WAS CONFIRMED AGAIN WHEN AN MRI EXAMINATION WAS PERFORMED. A SHUNT OBSTRUCTION WAS SUSPECTED, THEREFORE THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. THE CATHETER WAS ALSO REMOVED AND IT IS UNKNOWN IF IT WAS REPLACED.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 14567754 ↗
• InjuryMay 26, 2022Calcified; Calcified

  A PHYSICIAN REPORTED THEY NOTICED THE SHUNT WAS NOT FUNCTIONING AS IT SHOULD AND THEY PERFORMED A SURGERY TO REMOVE THE SHUNT AND THE BACTISEAL CATHETER (ID (B)(4)). HOWEVER, THEY JUST REMOVED THE CATHETER, IT WAS CALCIFIED AND BROKE INTO PIECES, SO THEY NEEDED TO TAKE THEIR TIME TO CUT OUT PIECE BY PIECE (ALSO ENLARGING THE INCISION). THE EVENT LED TO 30 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 14515031 ↗
• InjuryApr 6, 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: 3013886523-2022-00139 . A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A (B)(6) FEMALE PATIENT DUE TO SAH (SUBARACHNOID HEMORRHAGE) VIA L-P SHUNT ON (B)(6) 2022 WITH SETTING 3. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ) AND BACTISEAL PERITONEAL CATHETER (ID 823074-SERIAL;UNK). ON MARCH 11, THE PATIENT HAD DISORIENTATION. THE PRESSURE SETTING WAS CHANGED WITH ETK FOR FLUOROSCOPY (3 TO 2). ON MARCH, 17, THE PATIENT HAD DISORIENTATION. A SHUNT CONTRAST WAS PERFORMED, BUT NO OBSTRUCTION WAS OBSERVED. ON MARCH 18, NO IMPROVEMENT IN SYMPTOMS WAS SEEN, THE VALVE AND PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2022.

  Patient problems: Confusion/ Disorientation

  MAUDE report 14021990 ↗
• InjuryApr 5, 2022Migration; Migration

  A PHYSICIAN REPORTED THAT A PATIENT WHO HAD A VENTRICLE-PERITONEAL SHUNT PROCEDURE AND THE PERITONEAL CATHETER IS PROTRUDING THROUGH THE PATIENT¿S SKIN IN THE ABDOMEN. CATHETER WAS REPLACED ON (B)(6), 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017334 ↗