CODMAN® BACTISEAL® 823073 (REF 82-3073)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® Ventricular Catheter with BACTISEAL Shunt System MR CONDITIONAL Contents: Ventricular Catheter 14cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1) · Class 2 · Implant
All models of CODMAN BACTISEAL (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780536994), received between Aug 21, 2025 and Dec 25, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (2 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 Flow2
- Insufficient Device Problem Information1
Patient problems
- Cerebral Ventriculomegaly1
- Fever1
- Insufficient Information1
- Intracranial Hemorrhage1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjurySep 12, 2025Obstruction of Flow; Obstruction of Flow
InjuryAug 21, 2025Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED A BACTISEAL VENTRICULAR CATHETER (ID 823073) WAS IMPLANTED DUE TO COMMUNICATING AND ACQUIRED HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON AN UNSPECIFIED DATE WITH AN UNKNOWN SETTING. IT WAS USED WITH CERTAS VALVE (ID 828824). A SHUNT DYSFUNCTION WAS SUSPECTED DUE TO CEREBROSPINAL FLUID (CSF) FLOW COULD NOT BE CONFIRMED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. BASED ON THE ADDITIONAL INFORMATION, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS ANG SYMPTOMS DUE TO VALVE FAILURE. THE PATIENT CONDITION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22866233 ↗
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- 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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