Barrx 32041-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521189317), received between Aug 23, 2018 and Aug 23, 2018 — classified as 2 injuries.

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 2 most recent of 2 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

  ADULTS WITH DIAGNOSIS OF HIGH-GRADE DYSPLASIA (3) AND MUCOSAL SQUAMOUS CELL CARCINOMAS (7) UNDERWENT CIRCUMFERENTIAL ABLATIONS. FOUR OF THE 7 PATIENTS HAD A HISTORY OF HEAD AND NECK CANCERS, AND 4 HAD A HISTORY OF CIRRHOSIS. ALL PATIENTS HAD LESIONS THAT OCCUPIED MORE THAN HALF OF THE CIRCUMFERENCE OF THE ESOPHAGUS, AND 3 PATIENTS HAD CIRCUMFERENTIAL EXTENSION. PATIENTS UNDERWENT PRIMARY ABLATIONS CIRCUMFERENTIALLY USING THE HALO360 SYSTEM (CONCOMITANT PRODUCTS ENERGY GENERATOR, AND A SIZING BALLOON). ALL PATIENTS UNDERWENT CIRCUMFERENTIAL RFA WITH A DOUBLE-ABLATION REGIMEN (12 J/CM2¿ CLEAN ¿ 12 J/CM2). AFTER ENDOSCOPIC ABLATION, PATIENTS WERE PROVIDED WITH ESOMEPRAZOLE 40 MG/DAY AND SUCRALFATE SUSPENSION 5 ML (200 MG/ML) 4 TIMES DAILY FOR 1 MONTH. ACETAMINOPHEN AND AN ORAL NARCOTIC WERE PRESCRIBED AS NEEDED. PATIENTS LOGGED POSTABLATION SYMPTOMS TO RECORD CHEST PAIN, THROAT PAIN, ODYNOPHAGIA AND DYSPHAGIA. PATIENTS RECEIVED FOLLOW-UP ENDOSCOPY WITH IMAGE ENHANCING MODALITIES, INCLUDING LUGOL STAINING AND NARROW-BAND IMAGING. THIS WAS PERFORMED 1, 3, AND 6 MONTHS AFTER THE PROCEDURE AND EVERY 6 MONTHS THEREAFTER. IF RESIDUAL SQUAMOUS INTRAEPITHELIAL NEOPLASMS WERE DETECTED DURING F

  Patient problems: Blood Loss; Chest Pain; Fever; Hematoma; Pain; Stenosis

  MAUDE report 7810627 ↗
• 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: Blood Loss

  MAUDE report 7809562 ↗