CODMAN® BACTISEAL® NS0338Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® BACTISEAL® Clear with Barium Stripe Ventricular Catheter 15cm · Class 2 · Implant
- 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 10381780524052), received between Apr 2, 2024 and Aug 28, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Cerebrospinal Fluid Leakage1
- Hydrocephalus1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2024Migration; Migration
InjuryApr 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00099. MEDWATCH (B)(4). STUDY: 9 YEAR-OLD FEMALE PARTICIPANT. BIOMARIN STUDY: CERLIPONASE ALFA OBSERVATIONAL STUDY. "THE PARTICIPANT'S PAST MEDICAL HISTORY INCLUDED ANAEMIA, HORDEOLUM AND COVID-19. THE PARTICIPANT'S PAST MEDICAL PROCEDURES INCLUDED CATHETER PLACEMENT, MEDICAL DEVICE REMOVAL, CATHETER REMOVAL AND MEDICAL DEVICE IMPLANTATION. THE PARTICIPANT'S CONCURRENT CONDITIONS INCLUDED ANAEMIA, SKIN DISORDER, DERMATITIS ATOPIC, VISUAL IMPAIRMENT, EPILEPSY, DEVICE BREAKAGE, NEURONAL CEROID LIPOFUSCINOSIS, HYPERTONIA, DERMATITIS AND PYREXIA. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED PARACETAMOL, DIAZEPAM, CHLORHEXIDINE GLUCONATE, IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, BETAMETHASONE VALERATE, TACROLIMUS, TRIAMCINOLONE ACETONIDE, ASCORBIC ACID/CYANOCOBALAMIN/ERGOCALCIFEROL/FOLIC ACID/IRON/NICOTINAMIDE/PYRIDOXINE HYDROCHLORIDE/RETINOL/RIBOFLAVIN/THIAMINE HYDROCHLORIDE/TOCOPHEROL, PETROLATUM, CLOBAZAM AND LEVETIRACETAM. THE PARACETAMOL, CHLORHEXIDINE GLUCONATE, IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE AND LIDOCAINE HYDROCHLORIDE WAS ADMINISTERED AS PREMEDICATION." "ON (B
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19084711 ↗InjuryApr 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
Other CATHETER, VENTRICULAR devices
- CODMAN® HAKIM® BACTISEAL® NS5524Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR1 recall1 report
- CODMAN® BACTISEAL® NS0339Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR6 reports
- CODMAN® BACTISEAL® NS0340Integra Lifesciences Production Corporation · CATHETER, VENTRICULAR5 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.