CODMAN® BACTISEAL® 823074 (REF 82-3074)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® Distal Catheter Kit with BACTISEAL Shunt System MR CONDITIONAL Contents: Distal Catheter 120cm (1) · Class 2 · Implant
All models of CODMAN BACTISEAL (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780537007), received between Oct 24, 2024 and Dec 25, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow3
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Cerebral Ventriculomegaly1
- Cyst(s)1
- Fever1
- Fluid Discharge1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryOct 17, 2025Obstruction of Flow; Obstruction of Flow
InjuryJun 13, 2025Migration; Migration
EVENT REPORTED FROM A POST-MARKET CLINICAL PROGRAM: A FACILITY REPORTED A BACTISEAL PERITONEAL CATHETER AND A BACTISEAL VENTRICULAR CATHETER (ID 823073) WERE IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT REPORTED DISCOMFORT AT THE ABDOMINAL INCISION SITE WITH CLEAR FLUID DISCHARGE. AN ABDOMINAL CT SCAN REVEALED SUBCUTANEOUS DISPLACEMENT OF THE PERITONEAL END OF THE CATHETER. A PERITONEAL CATHETER REPOSITIONING SURGERY WAS PERFORMED ON (B)(6) 2022. POSTOPERATIVELY, THE ABDOMINAL INCISION HEALED SATISFACTORILY, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022.
Patient problems: Fluid Discharge
MAUDE report 22202055 ↗InjuryApr 23, 2025Obstruction of Flow; Obstruction of Flow
THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00082, 3013886523-2025-00083. 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 21894995 ↗InjuryOct 24, 2024Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A BACTISEAL PREITONEAL CATHETER (ID 823074) AND A CERTAS VALVE (ID 828804) WERE IMPLANTED ON (B)(6) 2024, DUE TO SECONDARY NORMAL PRESSURE HYDROCEPHALU (SNPH), VIA VENTRICULOPERITONEAL (VP) SHUNT. THE PATIENT DEVELOPED "VENTRICULAR DILATATION", THEREFORE, DUE TO OBSTRUCTION, THE DEVICES WERE REMOVED, AND THE PATIENT WAS PLACED ON EXTERNAL DRAINAGE. THEN, A NEW VALVE (COMPETITORS) WAS IMPLANTED.
Patient problems: Cerebral Ventriculomegaly
MAUDE report 20524519 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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