Barrx FLEXFS-010ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521181304), received between Oct 5, 2018 and Jul 17, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER 20 APPLICATIONS WITH THE CATHETER, IT STOPPED TO DELIVER ENERGY AND THEY GOT AN ERROR MESSAGE E92 "CLEAN ELECTRODE PRESS RESET". THEY TRIED TO CLEAN THE ELECTRODE AND DID A RESET WITH THE GENERATOR A FEW TIMES BUT IT DID NOT SOLVE THE PROBLEM. THE PROCEDURE WAS GASTRIC ANTRAL VASCULAR ECTASIA AND THE PATIENT CAME WITH CHRONIC BLEEDING FROM THE STOMACH. THE PROCEDURE WAS ABORTED AND A REPEAT PROCEDURE WILL BE NEEDED SCHEDULED ON ANOTHER DAY. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799413 ↗
• InjuryNov 26, 2018No Apparent Adverse Event; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, THE PATIENT HAD A RADIO FREQUENCY ABLATION OF BARRETT'S ESOPHAGUS AND WERE PRESENTED WITH MELENA AND A HEMOGLOBIN (HB) OF 76. FOUR UNITS OF BLOOD WERE GIVEN AND THE GASTROSCOPY WAS DONE WHICH SHOWED ULCERATIONS FROM THE PROCEDURE, BUT NO BLEEDING POINT. THERE WAS NO TREATMENT DONE DURING THE GASTROSCOPY. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA, BUT THERE WAS NO PATIENT HARM, AND NO REPEAT PROCEDURE WAS PERFORMED.

  Patient problems: Blood Loss; Ulceration

  MAUDE report 8103353 ↗
• InjuryNov 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER THE RADIO FREQUENCY ABLATION PROCEDURE OF BARRETT'S ESOPHAGUS, THE PATIENT WAS PRESENTED TO THE PHYSICIAN FOR FURTHER REVIEW AS THE PATIENT WAS VERY UNWELL. THE PHYSICIAN PERFORMED A GASTROSCOPY AND FOUND A RUPTURED ESOPHAGUS. AN URGENT ESOPHAGECTOMY WAS PERFORMED AND THE PATIENT WAS CURRENTLY STILL IN THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN ENVISAGED THE PATIENT TO BE IN THE HOSPITAL FOR APPROXIMATELY THREE MONTHS. PATHOLOGY SHOWED THAT THE TREATMENT WAS NOT A FULL THICKNESS BURN AND RESULTED IN A PERMANENT INJURY. THERE WAS NO ERROR MESSAGE OR CODE DISPLAYED. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS PUT UNDER ANESTHESIA, NO REPEAT PROCEDURE WAS NEEDED, AND THE PATIENT HAD A BOERHAAVE SYNDROME.

  Patient problems: Rupture

  MAUDE report 8074610 ↗
• InjuryOct 5, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE FOR HIGH GRADE DYSPLASIA, THE CATHETER FAILED TO INFLATE. THE CATHETER WILL BE RETURNED FOR INVESTIGATION. TWO WEEKS POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR GASTROINTESTINAL BLEEDING FROM ESOPHAGUS AND WAS ON ANTI-COAGULANT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7940622 ↗