Barrx 32041-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521189331), received between Aug 23, 2018 and Aug 23, 2018 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RETROSPECTIVE STUDY OF EIGHT PATIENTS WITH CIRRHOSIS (CHILD-PUGH SCORE _6) WITH EARLY FLAT-TYPE ESCNS (HIGH-GRADE INTRAEPITHELIAL NEOPLASIA/INTRAMUCOSAL CANCER, AND LUGOL UNSTAINED LESION [USL] LENGTH _3 CM EXTENDING _1/2 THE CIRCUMFERENCE) ON OR ADJACENT TO ESOPHAGEAL VARICES, FOR WHICH CIRCUMFERENTIAL RFA WAS APPLIED AS THE INITIAL TREATMENT. ALL PATIENTS RECEIVED BALLOON-BASED RFA AS THE INITIAL TREATMENT USING A HALO 360 SYSTEM (A BALLOON ABLATION CATHETER, AN ENERGY GENERATOR, AND A SIZING BALLOON) USING A 12 J/CM2, CLEAN, 12 J/CM2 REGIMEN TO TREAT THE FIRST 4 PATIENTS, AND DOUBLE ABLATION (12 J/CM2) WITHOUT CLEANING FOR THE OTHERS TO MINIMIZE THE RISK OF BLEEDING. AFTER THE RFA PROCEDURES, THE PATIENTS WERE GIVEN ESOMEPRAZOLE 40 MG DAILY AND SUCRALFATE SUSPENSION 5 ML (200 MG/ML) 4 TIMES DAILY FOR 1 MONTH. THE PATIENTS THEN RECEIVED FOLLOW-UP ENDOSCOPY AT 1, 3, AND 6 MONTHS AFTER THE PROCEDURE AND EVERY 6 MONTHS THEREAFTER. IF RESIDUAL SQUAMOUS INTRAEPITHELIAL NEOPLASMS WERE DETECTED, FOCAL-TYPE RFA (HALO 90 SYSTEM) (12 J/CM2, 3 APPLICATIONS) FOR HIGH-GRADE DYSPLASIA/MUCOSAL CANCER OR ARGON PLASMA COAGULATION USING COMPETITOR PRODUCT FOR LOW-GRADE DYSPLASIA WERE APPLIED EVERY

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 7810572 ↗