CODMAN BACTISEALRecalls & reported problems across all models
Cerenovus, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 7 models of CODMAN BACTISEAL by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2018 and Jun 6, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CODMAN BACTISEAL problems
Device problems
- Insufficient Device Problem Information9
- Obstruction of Flow6
- Adverse Event Without Identified Device or Use Problem3
- Disconnection3
- Fluid/Blood Leak3
- Break2
- Infusion or Flow Problem2
- Calcified1
Patient problems
- Insufficient Information5
- Cerebral Ventriculomegaly4
- Confusion/ Disorientation4
- Headache4
- Cerebrospinal Fluid Leakage3
- No Clinical Signs, Symptoms or Conditions3
- Fever2
- Fistula2
CODMAN BACTISEAL models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN BACTISEAL 82-3074Shunt, central nervous system and components12 reports
- CODMAN BACTISEAL 82-3072Shunt, central nervous system and components6 reports
- CODMAN BACTISEAL 82-3073Shunt, central nervous system and components4 reports
- CODMAN BACTISEAL NS0340Shunt, central nervous system and components4 reports
- CODMAN BACTISEAL 82-1750Shunt, central nervous system and components1 report
- CODMAN BACTISEAL NS0338Shunt, central nervous system and components1 report
- CODMAN BACTISEAL NS0339Shunt, central nervous system and components1 report
Recent CODMAN BACTISEAL adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗InjuryMay 2, 2024Obstruction of Flow; Obstruction of Flow
InjuryMar 24, 2024Break; Break
InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryAug 9, 2023Obstruction of Flow; Obstruction of Flow
InjuryJul 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryFeb 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
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 ↗InjuryJan 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00543. A FACILITY REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED VIA UNKNOWN SHUNT ON UNKNOWN DATE / SETTING. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). AND BACTISEAL PERITONEAL CATHETER (ID NS0339 SERIAL; UNK). ON (B)(6) 2022, THE PATIENT PRESENTED WITH DISORIENTATION AND SHUNT IMAGING WAS PERFORMED. VENTRICULAR ENLARGEMENT WAS OBSERVED; THEREFORE, SHUNT OBSTRUCTION WAS SUSPECTED, AND LUMBER CATHETER RUPTURE WAS ALSO CONFIRMED THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.
Patient problems: Confusion/ Disorientation
MAUDE report 15753855 ↗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 ↗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 ↗
Other Cerenovus, Inc. products
- GALAXY G358 models · 1,386 reports · 1 recall
- CODMAN41 models · 107 reports · 22 recalls
- MICRUSFRAME47 models · 298 reports
- DELTAFILL29 models · 294 reports
- CEREPAK FREEFORM60 models · 166 reports · 1 recall
- CEREBASE3 models · 143 reports · 1 recall
- DELTAXSFT13 models · 130 reports
- CEREPAK UNIFORM58 models · 33 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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