Barrx 90-9300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521189386), received between Sep 24, 2019 and May 1, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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. 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.

• InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLI 20: ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED BETWEEN JANUARY 2007 AND AUGUST 2017, 1 PATIENT DEVELOPED STRICTURES AND DILATIONS WAS DONE AFTER THE RADIO FREQUENCY PROCEDURE. THE COMPARISON OF TWO RFA PROTOCOLS WHICH WAS 1 NON LABEL ( STANDARD) AND 1 OFF LABEL ( SIMPLIFIED) HAD MULTIPLE ADVERSE EVENT. 10 PATIENTS DEVELOPED ESOPHAGEAL STRICTURES FOLLOWING RFA (1 PATIENT IN STANDARD GROUP AND 9 PATIENTS IN SIMPLIFIED GROUP), WHICH WERE CLASSIFIED BY THE AUTHORS AS ¿COMPLICATIONS FROM RFA¿. STRICTURES WERE DILATED, WITH A MEDIAN OF 1 DILATION SESSION REQUIRED. 2 PATIENTS REQUIRED >2 DILATIONS (1 PATIENT REQUIRED 2 DILATIONS, 1 PATIENT REQUIRED 7 DILATIONS). THE SIMPLIFIED PROTOCOL WAS ASSOCIATED WITH 11 TIMES GREATER ODDS OF DEVELOPING STRICTURES COMPARED TO THE STANDARD PROTOCOL. TYPE OF RFA DEVICE WAS NOT ASSOCIATED WITH RISK OF STRICTURE. OF THE 12 PATIENTS THAT NEEDED RESCUE-EMR, 1 PATIENT DEVELOPED A STRICTURE. 2 PATIENTS TREATED WITH THE STANDARD PROTOCOL HAD SERIOUS ADVERSE EVENTS AS JUDGED BY THE AUTHORS. 1 PATIENT HAD SYMPTOMATIC ATRIAL FIBRILLATION WITHIN 36HR OF TWO ABLATION SESSIONS (1 CIRCUMFERENTIAL AND 1 FOCAL) AND NEEDED PHARMACOLOGICAL CARDIOVERSIO

  Patient problems: Atrial Fibrillation; Chest Pain; Dysphagia/ Odynophagia; Laceration(s) of Esophagus

  MAUDE report 10017039 ↗
• MalfunctionSep 24, 2019Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING THE EGD (ESOPHAGOGASTRODUODENOSCOPY) OF THE BARRETT'S PROCEDURE, THE CABLE WOULD NOT CONNECT TO ANY OF THE CATHETERS. THE CUSTOMER OPENED 4 PACKAGES. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. THE PROCEDURE WAS ABORTED AND A REPEAT PROCEDURE WAS NECESSARY. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112635 ↗