Barrx 32041-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521189324), received between Aug 24, 2018 and Aug 31, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 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 NE OPLASIA/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 EVER

  Patient problems: Hematoma

  MAUDE report 7839606 ↗
• InjuryAug 31, 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: Chest Pain; Fever; Pain

  MAUDE report 7839491 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST RADIO FREQUENCY ABLATION PROCEDURE, THE PATIENT EXPERIENCED DYSPHAGIA TWICE AND IT WAS CONSIDERED TO BE AN ESOPHAGEAL STENOSIS. ESOPHAGEAL DILATION WAS REQUIRED SCHEDULED ON A DIFFERENT DAY. THE SIZE OF ESOPHAGEAL MEASURED AS 25MM IN 24-32CM, 18MM IN 20CM. SO THEY CONDUCTED A RADIO FREQUENCY ABLATION IN 26-32 CM USING A DEVICE, AND THEN EXITED THE MEASURING BALLOON, CONDUCTED RFA ABLATION IN 20-26 CM USING A DEVICE. EACH ABLATION CATHETER WAS ABLATED TWICE, SO IT WAS ABLATED FOUR TIMES. ENDOSCOPY HAS BEEN PERFORMED PRIOR TO CATHETER INTUBATION AND FOUND NO VARICES, ESOPHAGITIS, ONLY THE ESOPHAGEAL SIZE WAS 18MM IN THE SECTION OF 20CM AFTER MEASURED BY THE BALLOON CATHETER. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE, NO DEVICE MALFUNCTION WAS NOTICED. WHEN ESOPHAGEAL DILATION WAS PERFORMED, THEY NOTED THAT THE STENOSIS AREA ON THE ESOPHAGEAL WAS 25 CM. THEY THEN INSERTED THE DILATION GUIDE WIRE, BUT THE 9.9MM ENDOSCOPY COULD NOT GO ACROSS THE STENOSIS AREA. THEY USED A 7MM BOUGIE (A THIN AND FLEXIBLE SURGICAL INSTRUMENT) AND TRIED TO INSERT THE 9 MM ENDOSCOPY TO HAVE DILATION, BUT THE ENDOSCOPY CAN NOT GO CROSS. THE PATIENT WILL COME BACK AGAIN FOR

  Patient problems: Dysphagia/ Odynophagia; Laceration(s) of Esophagus; Stenosis

  MAUDE report 7813170 ↗