Barrx CP-002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521189423), received between Sep 4, 2019 and Sep 4, 2019 — 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.

• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RADIO FREQUENCY ABLATION OF BARRETT'S ESOPHAGUS EXTENDING UP FROM ESOPHAGOGASTRIC JUNCTION (EGJ), THEY WERE SCRAPING A LITTLE TOO AGGRESSIVELY IN THE COAGULUM FROM THE ESOPHAGEAL WALL AFTER THE FIRST PASS, THEN A PERFORATION OCCURRED IN THE FOLDS OF THE EGJ. THERE WAS NEVER ANY RESISTANCE ON THE BALLOON OR SCOPE AT ANY TIME DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THIS WAS A USER ERROR BUT WOULD LIKE THE CLEANING CAP TO BE INSPECTED AS IT SEEMED SHARPER THAN THE USUAL. THE PATIENT HAD A PRE-EXISTING CONDITION OF OBESITY, GASTROESOPHAGEAL REFLUX DISEASE (GERD), AND CHRONIC DIARRHEA. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. THEY PERFORMED GASTROGRAFFIN SWALLOW TWICE TO RULE OUT THE PERFORATION AND THE PERFORATION WAS CLOSED USING CLIPS. THE PATIENT WAS MONITORED OVER WEEKEND, TREATED WITH "IV ABX" AND WAS DISCHARGED.

  Patient problems: Perforation

  MAUDE report 8960238 ↗