CODMAN® BACTISEAL® 823072 (REF 82-3072)Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with BACTISEAL Shunt System MR CONDITIONAL contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1); Additional Contents: Stylet (1) · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780536987), received between Feb 5, 2025 and Jun 12, 2026 — classified as 5 injuries, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow3
- Chemical Problem1
- Insufficient Device Problem Information1
- Positioning Failure1
Patient problems
- Unspecified Infection2
- Cerebral Ventriculomegaly1
- Convulsion/Seizure1
- Diaphoresis1
- Dizziness1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Insufficient Device Problem Information
InjuryMay 12, 2026Obstruction of Flow
A FACILITY REPORTED A BACTISEAL CATHETER (ID: 823072) AND A CERTAS VALVE WERE IMPLANTED VIA VENTRICULOPERITONEAL (V-P) SHUNT. THE VALVE AND THE BACTISEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2026 DUE TO SUSPICION OF OBSTRUCTION. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT HAD ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE.
Patient problems: Insufficient Information
MAUDE report 25148810 ↗InjuryMay 1, 2026Obstruction of Flow
InjuryOct 31, 2025Obstruction of Flow; Obstruction of Flow
MalfunctionMay 7, 2025Chemical Problem; Chemical Problem
A FACILITY REPORTED: WHEN THE VENTRICULAR CATHETER WAS FLUSHED, THE FLUSH CAME OUT ORANGE AND THERE WAS CONCERN THAT THE CLINDAMYCIN MAKE HAVE BEEN LEACHING OUT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977131 ↗InjuryFeb 5, 2025Positioning Failure; Positioning Failure
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- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.