CODMAN® BACTISEAL® 823074 (REF 82-3074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10381780515630), received between Mar 22, 2023 and Mar 6, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Obstruction of Flow

  A FACILITY REPORTED A CERTAS VALVE (ID 828814) AND BACTISEAL PERITONEAL CATHETER (ID 823074) WERE IMPLANTED IN 2023 DUE TO UNKNOWN REASON VIA VENTRICULOATRIAL (VA) SHUNT AT AN UNKNOWN SETTING. ON (B)(6) 2026, THE VALVE AND CATHETER WERE REMOVED DUE TO SUSPICION OF OBSTRUCTION. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO THE SUSPICION OF OBSTRUCTION. IT IS ALSO UNKNOWN WHAT THE CURRENT STATUS OF THE PATIENT IS.

  Patient problems: Insufficient Information

  MAUDE report 24532744 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak; No Apparent Adverse Event

  N/A.

  Patient problems: Cerebrospinal Fluid Leakage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034753 ↗
• InjuryMar 21, 2025Break; Break

  A PHYSICIAN REPORTED THAT A PERITONEAL CATHETER (ID: 823074) IMPLANTED IN A PATIENT WITH HYDROCEPHALUS APPROXIMATELY 2 YEARS AGO HAD RUPTURED IN THE ABDOMEN. THEREFORE, THE CATHETER WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT IS STABLE AND HAS NOT EXPERIENCED ANY SIGNS OR SYMPTOMS DUE TO THE DEVICE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21664253 ↗
• InjuryJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00405, 3013886523-2024-00406. A FACILITY REPORTED THAT A PATIENT WAS SENT TO THE HOSPITAL DUE TO HYDROCEPHALUS, COMA, GRADE III HYPERTENSION, PNEUMONIA, AND SEQUELAE OF CEREBRAL HEMORRHAGE. ON (B)(6) 2024, A HAKIM VALVE (ID (B)(6)), A BACTISEAL VENTRICULAR CATHETER (ID (B)(6)), AND A BACTISEAL PERITONEAL CATHETER (ID (B)(6)) WERE IMPLANTED. ON (B)(6) 2024, THE PATIENT¿S HYDROCEPHALUS DID NOT IMPROVE, AND THE VALVE PRESSURE WAS ADJUSTED EIGHT TIMES; HOWEVER, THE PRESSURE COULD NOT BE ADJUSTED. ON (B)(6) 2024, THE PHYSICIAN IMPLANTED A NEW VALVE AND TWO CATHETERS INTO THE PATIENT'S RIGHT CEREBRAL VENTRICLE. DUE TO THE PATIENT'S CONDITION, THE PHYSICIAN LEFT THE VALVE IN THE PATIENT. THERE IS NO PLAN TO REMOVE THE VALVE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS AN ISSUE OR A FAILURE WITH THE TWO CATHETERS AND IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO THE DEVICES ISSUE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21093313 ↗
• InjurySep 20, 2024Migration; Migration

  THIS IS 1 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00289, 3013886523-2024-00290, 3013886523-2024-00292, 3013886523-2024-00296, 3013886523-2024-00297, 3013886523-2024-00298. A PATIENT REPORTED A VALVE (UNKNOWN ID), VENTRICULAR CATHETER (UNKNOWN ID) AND A PERITONEAL CATHETER (UNKNOWN ID) WAS IMPLANTED ON (B)(6) 1997. IN (B)(6) 2024, THE PATIENT HAD INDICATION OF FAILING VALVE AND CATHETERS. THE PATIENT UNDERWENT 6 REVISIONS, 5 OF WHICH WERE CAUSED BY HIS BODY REJECTING THE CATHETER AND IT WAS DRAINING CEREBROSPINAL FLUID (CSF) OUTSIDE THE CAVITY AND UNDER THE SKIN WHERE IT COULD NOT BE ABSORBED. REVISIONS: #1 - (B)(6) 2024: OLD VALVE AND VENTRICULAR CATHETER WERE REPLACED WITH A CODMAN VALVE (UNKNOWN ID) AND BACTISEAL PERITONEAL CATHETER (ID 823074). #2 - (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PERITONEAL CAVITY AND WAS REPOSITIONED. #3 - (B)(6) 2024: OLD VENTRICULAR CATHETER WAS REPLACED. #4 - (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PERITONEAL CAVITY AND WAS REPOSITIONED. #5 - (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PERITONEAL CAVITY AND REINSERTED INTO THE PLEURAL CAVITY. #6 - (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PLEURAL CAVITY THEREFORE, IT WAS

  Patient problems: Insufficient Information

  MAUDE report 20274611 ↗
• InjuryMay 24, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A PHYSICIAN REPORTED A BACTISEAL PERITONEAL CATHETER (ID 823074) AND CERTAS VALVE (ID 828804) WERE IMPLANTED VIA LUMBAR PERITONEAL (LP) SHUNT DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) ON (B)(6) 2024, WITH UNKNOWN SETTING. THE VALVE WAS USED WITH SILASCON® LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). UNDERDRAINAGE CAUSED VENTRICULAR DILATATION AFTER THE SURGERY, AND THE PATIENT'S CLINICAL CONDITION WORSENED. A NEW VALVE WAS IMPLANTED VIA VENTRICULAR PERITONEAL (VP) SHUNT ON (B)(6) 2024, DUE TO SUSPICION OF DEVICE OBSTRUCTION. THE BLOOD CLOT WAS OBSERVED INSIDE THE EXPLANTED VALVE. ALTHOUGH A FLOW TEST WAS CONDUCTED ON THE EXPLANTED LUMBAR CATHETER, FLOW COULD NOT BE CONFIRMED. ACCORDING TO THE DOCTOR, LUMBAR PUNCTURES WERE PERFORMED REPEATEDLY DURING THE SURGERY ON (B)(6) 2024, WHICH MAY HAVE CAUSED AN INFLUX OF BLOODY CEREBROSPINAL FLUID (CSF) INTO THE SHUNT DEVICE. THE PATIENT'S PRIMARY DISEASE IS SUBARACHNOID HEMORRHAGE AND IS CURRENTLY IN A FOLLOW-UP STATUS. ACCORDING TO INFORMATION PROVIDED, IT IS NOT KNOWN IF THE OBSTRUCTION WAS OBSERVED IN THE PERITONEAL CATHETER. IT IS ALSO UNKNOWN IF THE CATHETER WAS REMOVED AND REPLACED.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 19391935 ↗
• InjuryApr 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: Cerebral Edema

  MAUDE report 19054386 ↗
• InjuryFeb 1, 2024Obstruction of Flow; Obstruction of Flow

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3013886523-2024-00013. A PHYSICIAN REPORTED A CERTAS VALVE (828804) AND A BACTISEAL CATHETER (823074) WERE IMPLANTED DUE TO COMMUNICATING HYDROCEPHALUS AND SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) VIA LUMBOPERITONEAL SHUNT ON (B)(6), 2023 WITH SETTING 2. THE PATIENT HAD HEADACHES AND DEVELOPED VENTRICLE DILATION. AN OBSTRUCTION WAS FOUND, THEREFORE A REVISION SURGERY WAS PERFORMED. THE VALVE AND THE CATHETER WERE EXPLANTED AND REPLACED WITH A NEW CERTAS VALVE (828804) AND A NEW PERITONEAL CATHETER (823074) ON (B)(6), 2023. THE SETTING OF THE VALVE WAS 2 WHEN EXPLANTED. THE PATIENT HAS RECOVERED.

  Patient problems: Cerebral Ventriculomegaly; Headache

  MAUDE report 18627236 ↗
• InjuryOct 10, 2023No Flow; No Flow

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906483 ↗
• InjuryAug 15, 2023Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Fever; High Blood Pressure/ Hypertension; Unspecified Infection

  MAUDE report 17551621 ↗
• InjuryAug 9, 2023Obstruction of Flow; Obstruction of Flow

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00248. MEDWATCH MW5119303: "THE REPORTER CALLED, STATING THAT HER DAUGHTER HAS HAD NUMEROUS HEALTH PROBLEMS AND REPORTING MEDICAL COVER-UPS BY MULTIPLE HEALTHCARE PERSONNEL AND HEALTHCARE ORGANIZATIONS EVER SINCE HER DAUGHTER WAS IMPLANTED WITH NERVOUS SYSTEM SHUNTS AND CATHETERS. REPORTER STATES HER DAUGHTER HAS HAD "OVER 110 HIGH-DOSE CT SCANS" OF HER BRAIN. REPORTER STATES COVER-UPS BY HEALTHCARE PERSONNEL INCLUDE A FALL THAT HER DAUGHTER SUFFERED WHILE BEING TREATED IN THE EMERGENCY ROOM, AN EXPIRED DEVICE THAT WAS IMPLANTED IN HER DAUGHTER, POSITION PROBLEMS WITH THE CATHETER, SHUNTS NOT DRAINING CORRECTLY AS WELL AS A BLOCKED SHUNT, AND BRAIN DAMAGE INCLUDING ENCEPHALOMALACIA. REPORTER STATES HER DAUGHTER HAS SUFFERED "SEIZURES AND HEAD PAIN" AND EVEN RESPIRATORY FAILURE IN 2022. REPORTER STATES SHE HAS CONCERNS THAT "THEY HAVE NEVER RUN A SHUNTOGRAM". REPORTER STATES THE DEVICE VIBRATES AND CAUSES HER DAUGHTER PAIN. "

  Patient problems: Brain Injury; Convulsion/Seizure; Headache

  MAUDE report 17487933 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00253. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) AND BACTISEAL PERITONEAL CATHETER (ID 823074) WERE IMPLANTED VIA LUMBAR PERITONEAL SHUNT ON (B)(6)2023 WITH UNKNOWN SETTING. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ), AND BACTISEAL PERITONEAL CATHETER (ID 823074) (SERIAL;UNK). THE PATIENT'S SYMPTOMS WORSENED FROM MID-JUNE. DUE TO SUSPICION OF OBSTRUCTION, THE VALVE AND THE CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17482233 ↗
• InjuryJul 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 17299923 ↗
• InjuryMar 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00077. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828800) WAS IMPLANTED IN (B)(6) 2022 DUE SUBARACHNOID HEMORRHAGE VIA LUMBAR PERITONEAL SHUNT WITH SETTING 3. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ) AND WITH PERITONEAL CATHER ( ID 823074). ON (B)(6) 2023, THE SETTING WAS CHANGED FROM 3 TO 2 BECAUSE THE VENTRICLES DID NOT SHRINK. ON (B)(6) 2023, AN X-RAY WAS TAKEN, HOWEVER, THE VENTRICLES STILL DID NOT SHRINK, SO SETTING 2 WAS CHANGED TO 1. ON (B)(6) 2023, THE SHUNT SYSTEM WAS REMOVED AND REPLACED BECAUSE THE VENTRICLE STILL DID NOT SHRINK EVEN IN SETTING 1. THE PATIENT HAD GAIT DISTURBANCE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16592550 ↗