CODMAN® BACTISEAL® 823073 (REF 82-3073)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10381780515623), received between May 25, 2023 and Feb 20, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Detachment of Device or Device Component

  A PHYSICIAN REPORTED A BACTISEAL VENTRICULAR CATHETER (ID 823073) WAS IMPLANTED FOR AN UNKNOWN REASON VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2024. THERE WAS A SUSPICION THAT THE VENTRICULAR CATHETER HAD DISLODGED. THEREFORE, THE VENTRICULAR CATHETER WAS REPLACED ON (B)(6) 2026. THE PATIENT¿S CONDITION DID NOT IMPROVE, SO THE SHUNT SYSTEM, INCLUDING THE VALVE AND VENTRICULAR CATHETER, WERE EXPLANTED ON (B)(6) 2026. ACCORDING TO INFORMATION PROVIDED, THE SHUNT SYSTEM WAS EXPLANTED ON (B)(6) 2025 (IMPLANTED AS REPLACEMENTS ON (B)(6) 2025); HOWEVER, IT IS UNKNOWN IF THE PRODUCTS ARE INTEGRA.

  Patient problems: Insufficient Information

  MAUDE report 24400433 ↗
• InjuryAug 14, 2025Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 22809218 ↗
• InjuryApr 23, 2025Obstruction of Flow; Obstruction of Flow

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00082, 3013886523-2025-00084. A FACILITY REPORTED A HAKIM VALVE (ID: 823832), A BACTISEAL VENTRICULAR CATHETER (ID: 823073), AND A BACTISEAL PERITONEAL CATHETER (ID: 823074) WERE IMPLANTED ON (B)(6) 2025. AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUBCUTANEOUS HYDROPS. THEREFORE, THE PRODUCTS WERE REMOVED AND REPLACED DUE TO SUSPICION OF OCCLUSION. THE PATIENT IS STABLE.

  Patient problems: Cyst(s)

  MAUDE report 21894803 ↗
• InjuryMar 7, 2025Obstruction of Flow; Obstruction of Flow

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00051. A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814), BACTISEAL VENTRICULAR CATHETER (ID 823073) AND BACTISEAL PERITONEAL CATHETER (ID 823074) WERE IMPLANTED DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALUS (SNPH) AND BRAIN TUMOR, VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2025 WITH SETTING 3. AFTER THE SURGERY, THE VENTRICLE SHRUNK, AND THE CONDITION HAD IMPROVED. ON (B)(6) 2025, THE PATIENT DEVELOPED VENTRICULAR DILATATION AGAIN AND SUFFERED FROM A HEADACHE. THE PRESSURE SETTING WAS CHANGED FROM 3 TO 1, BUT THERE WAS NO SIGN OF IMPROVEMENT. THEREFORE, THE SHUNT AND CATHETER WERE REMOVED ON (B)(6) 2025, AND THE PATIENT IS ON EXTERNAL DRAINAGE. OBSTRUCTION WAS SUSPECTED ON THE CATHETER. THEY ARE PLANNING TO IMPLANT A NEW DEVICE VIA VP SHUNT.

  Patient problems: Cerebral Ventriculomegaly; Headache

  MAUDE report 21546838 ↗
• InjuryJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00405. 3013886523-2024-00407. 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 823832), A BACTISEAL VENTRICULAR CATHETER (ID 823073), AND A BACTISEAL PERITONEAL CATHETER (ID 823074) 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 21093309 ↗
• InjuryDec 12, 2024Obstruction of Flow; Obstruction of Flow

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2023-00395, 3013886523-2024-00384. A FACILITY REPORTED A HAKIM VALVE (ID 823832), A BACTISEAL PERITONEAL CATHETER (ID 823074) AND A BACTISEAL VENTRICULAR CATHETER (ID 823073) WERE IMPLANTED ON (B)(6) 2023 AND ON (B)(6) 2023, THE PHYSICIAN FOUND OUT THAT A CATHETER WAS OBSTRUCTED (CUSTOMER COULD NOT CONFIRM WHICH CATHETER WAS OBSTRUCTED); THEREFORE THE HAKIM VALVE, THE PERITONEAL AND VENTRICULAR CATHETERS WERE REMOVED ON (B)(6) 2023. THE PATIENT HAS INFECTIOUS DISEASE - HUMAN IMMUNODEFICIENCY VIRUS (HIV) WITH HISTORY OF TUBERCULAR MENINGITIS. THE PATIENT IS STABLE AFTER THE REVISION. INFECTION NOT RELATED TO VALVE OR CATHETERS.

  Patient problems: Insufficient Information

  MAUDE report 20914842 ↗
• InjuryDec 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  N/A.

  Patient problems: Hydrocephalus; Sleep Dysfunction

  MAUDE report 20864477 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED A CERTAS VALVE (ID 828805), A VENTRICULAR CATHETER (ID 823073) AND A PERITONEAL CATHETER WERE IMPLANTED ON (B)(6) 2024, WITH A VALVE SETTING AT 1. DUE TO THE GROWTH OF THE CEPHALIC PERIMETER, PATIENT EXPERIENCED WEAKNESS AND DROWSINESS; THEREFORE SURGICAL INTERVENTION WAS REQUIRED AFTER IMPLANTATION. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE CEREBROSPINAL FLUID (CSF) WAS FLOWING SLOWLY AND NOT IN A SUFFICIENT VOLUME THROUGH THE PERITONEAL CATHETER. THE VENTRICULAR CATHETER WAS CUT, AND A SUFFICIENT, AMPLE, AND CLEAR CSF DRIP WAS OBSERVED. THE VALVE AND VENTRICULAR CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2024. THE PERITONEAL VALVE WAS NOT EXPLANTED.

  Patient problems: Fatigue; Hydrocephalus

  MAUDE report 20086824 ↗
• InjuryAug 27, 2024Disconnection; Disconnection

  N/A.

  Patient problems: Vomiting

  MAUDE report 20081531 ↗
• InjuryMay 30, 2024Obstruction of Flow; Obstruction of Flow

  A FACILITY REPORTED A BACTISEAL VENTRICULAR CATHETER (ID 823073) WAS IMPLANTED ON (B)(6) 2024. THE PATIENT'S VENTRICLE WAS STILL ENLARGED AND THERE WAS NO CHANGE AFTER ADJUSTING THE PRESSURE. THE PHYSICIAN HAD A SUSPICION THAT THERE WAS AN OCCLUSION IN THE CATHETER. ON (B)(6) 2024 THE CATHETER WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. DURING THE REVISION, IT WAS CONFIRMED THAT THE VENTRICULAR CATHETER WAS OCCLUDED. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 19430423 ↗
• InjuryApr 12, 2024Obstruction of Flow; Obstruction of Flow

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3013886523-2024-00116: A FACILITY REPORTED THAT THE BACTISEAL VENTRICULAR CATHETER (823073) WAS EXPLANTED DUE TO SUSPICION OF OBSTRUCTION. THE PRESSURE SETTING ON THE VALVE WAS CHANGEABLE. THE IMPLANT AND EXPLANT DATES ARE UNKNOWN, AND PATIENT INFORMATION IS ALSO UNKNOWN. THERE WAS NO SURGICAL DELAY. REOPERATION WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Insufficient Information

  MAUDE report 19101921 ↗
• InjuryNov 15, 2023Obstruction of Flow; Obstruction of Flow

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2023-00381. A PHYSICIAN REPORTED THAT A CERTAS VALVE (828804) WAS IMPLANTED ON UNKNOWN DATE WITH UNKNOWN SETTING AFTER A CEREBELLAR HEMORRHAGE. THE PATIENT HAD SHUNT INFECTION ON UNKNOWN DATE. CURRENTLY, THERE IS NO INFECTION, HOWEVER A PATIENT HAD VENTRICULAR ENLARGEMENT. ALTHOUGH SETTING WAS CHANGED TO 1, BUT VENTRICULAR WAS STILL ENLARGED. DEBRIS WAS SEEN IN THE PERITONEAL CATHETER WHICH WAS REMOVED BY FLUSHING. ON (B)(6) 2023, THE VALVE AND THE VENTRICULAR CATHETER (ID 823073) WERE REMOVED AND REPLACED DUE TO SUSPICION OF OCCLUSION, AND THE PERITONEAL CATHETER REMAINED IMPLANTED. A 30 MINUTE DELAY WAS NOTED. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE IMPLANTATION DATE OF THE VENTRICULAR CATHETER (ID 823073) IS UNKNOWN. IT IS UNKNOWN IF THERE IS A FAILURE WITH THE PERITONEAL CATHETER. IT IS ALSO UNKNOWN IF THERE IS A PLAN TO REMOVE THE PERITONEAL CATHETER.

  Patient problems: Cerebral Ventriculomegaly

  MAUDE report 18142633 ↗
• MalfunctionOct 10, 2023No Flow; No Flow

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00349. 3013886523-2023-00351. A PHYSICIAN REPORTED THAT DURING SURGERY, CEREBROSPINAL FLUID FLOW WAS CONFIRMED WHEN THE VENTRICULAR CATHETER WAS INSERTED. HOWEVER, NO CEREBROSPINAL FLUID FLOW WAS OBSERVED AFTER THE CERTAS VALVE (828800), BACTISEAL PERITONEAL CATHETER (823074), AND BACTISEAL VENTRICULAR CATHETER (823073) WERE CONNECTED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED AND THE EVENT LED TO MORE THAN 30 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906714 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00233. A FACILITY REPORTED A HAKIM VALVE (ID 823184) AND A BACTISEAL VENTRICULAR CATHETER (ID 23073) WERE IMPLANTED VIA VENTRICULAR PERITONEAL (VP) SHUNT IN (B)(6) 2023. ON (B)(6) 2023 THE VALVE APPEARED TO BE OCCLUDED WHILE THE PROXIMAL CATHETER HAS A VISIBLE FLOW; THEREFORE, THE VALVE AND CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2023. ACCORDING TO INFORMATION PROVIDED, THERE WAS NO KNOWN ISSUE WITH THE CATHETER HOWEVER, THE VENTRICULAR CATHETER WAS REPLACED. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO VALVE MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 17405192 ↗
• InjuryJul 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Confusion/ Disorientation; Headache; Vomiting

  MAUDE report 17395974 ↗
• MalfunctionMay 25, 2023Contamination; Contamination

  A FACILITY REPORTED THAT AFTER UNPACKING THE DEVICE, THE PHYSICIAN FOUND THAT THERE IS WHITE FOREIGN MATTER ON THE BACTISEAL CATHETER (ID 823073). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007249 ↗