CODMAN® BACTISEAL® NS0339Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® Clear with Barium Stripe Distal Catheter 120cm, Includes: Information Manual · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780524069), received between Feb 15, 2023 and Aug 28, 2024 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available1
- Material Twisted/Bent1
- Obstruction of Flow1
Patient problems
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2024Material Twisted/Bent; Material Twisted/Bent
InjuryApr 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00098. A PHYSICIAN REPORTED A BACTISEAL BARIUM CATHETER (ID: NS0339) WAS IMPLANTED ON (B)(6) 2024, VIA VENTRICULOPERITONEAL SHUNT (VP). THE PATIENT DEVELOPED PANCYTOPENIA. THE PATIENT DEVELOPED NEUTROPENIA AFTER RECEIVING TWO INJECTIONS OF GRANULOCYTE COLONY STIMULATING FACTOR (G-CSF). THE BACTISEAL WAS USED TOGETHER WITH BACTISEAL (ID: NS0338) AND CERTAS VALVE (ID: 828804). ON (B)(6) 2024, THE VALVE WAS PUNCTURED, AND CEREBROSPINAL FLUID (CSF) WAS EXTRACTED. THEREFORE, ALL THREE DEVICES WERE REMOVED ON THE SAME DAY. ACCORDING TO INFORMATION PROVIDED, THE CAUSAL RELATIONSHIP BETWEEN THE INCIDENT AND THE PRODUCT IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PRODUCTS WERE REPLACED, HOWEVER, THE PATIENT'S CONDITION WAS REPORTED AS STABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19193782 ↗MalfunctionApr 19, 2024Obstruction of Flow; Obstruction of Flow
InjurySep 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00317. A FACILITY REPORTED A CERTAS VALVE (ID (B)(6)) WAS IMPLANTED VIA L-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE VALVE WAS USED WITH SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ), AND BACTISEAL PERITONEAL CATHETER (ID (B)(6)) (SERIAL: UNK). THE SHUNT SYSTEM WAS SUSPECTED TO BE OCCLUDED, THEREFORE, THE PATIENT HAD REVISION SURGERY. ACCORDING TO INFORMATION PROVIDED IT IS UNKNOWN IF THE CATHETER WAS OBSTRUCTED; HOWEVER IT WAS REMOVED. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED SIGNS AND SYMPTOMS OF OBSTRUCTION.
Patient problems: Insufficient Information
MAUDE report 17744457 ↗InjurySep 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionFeb 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
Other CATHETER, VENTRICULAR devices
- CODMAN® HAKIM® BACTISEAL® NS5524Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR1 recall1 report
- CODMAN® BACTISEAL® NS0340Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR5 reports
- CODMAN® BACTISEAL® NS0338Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR3 reports
- AESCULAP FV077PChristoph Miethke GmbH & Co. KG · CATHETER, VENTRICULAR2 reports
- CODMAN® CERTAS® Plus 828827PLIntegra LifeSciences Switzerland Sàrl · CATHETER, VENTRICULAR1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.