Barrx 64082Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521581876), received between Feb 25, 2025 and Nov 7, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, AFTER THE SECOND ROUND OF TREATMENT, A RESISTANCE WAS ENCOUNTERED WHEN TRYING TO REMOVE THE CATHETER FOR THE FINAL TIME. UNDER VISUALIZATION, THE ELECTRODE DID SEEM TO BE UNRAVELED. DOCTOR WAS FURTHER INSTRUCTED TO ROTATE THE CATHETER CLOCKWISE WHEN INTRODUCING AND REMOVING THE CATHETER WHICH RESOLVED THE ISSUE. THE PATIENT HAD TO UNDERGO CT SCAN AND SEEN A "SMALL DEFECT IN ESOPHAGUS T4-T5" WHICH WAS DONE NEXT DAY. THE PATIENT HAD TO EXTEND THE LENGTH OF STAY FOR 7 DAYS AND WAS ON CLEAR FLUIDS FOR 6 DAYS AND FULL FLUID DIET ON THE (B)(6). NO OTHER SURGICAL INTERVENTION NOTED AND NO ADDITIONAL PROCEDURES WERE NOTED IN HOSPITAL RECORDS.

  Patient problems: Perforation of Esophagus

  MAUDE report 23496309 ↗
• InjurySep 11, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE DOCTOR STARTED TO APPLY THE THERAPY TO THE PATIENT. BUT FOR SOME REASON THE DELIVERY OF THE ENERGY FROM THE CATHETER TO THE PATIENT'S ESOPHAGUS MUCOSA FAILED. THE CASE WAS CANCELED AND WAS REPEATED TWO WEEKS LATER WHEN IT WAS COMPLETED WITHOUT ANY ISSUES WITH ANOTHER GENERATOR. THE PATIENT UNDERWENT IV SEDATION ON BOTH INITIAL AND SECOND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031145 ↗
• MalfunctionJun 26, 2025Failure to Unfold or Unwrap; Premature Separation; Failure to Unfold or Unwrap; Premature Separation

  IT WAS REPORTED THAT DURING TWO TIMES RADIOFREQUENCY ABLATION (RFA) IN THE ESOPHAGUS AFTER BARRETT CARCINOMA FOR ERADICATION OF BARRETT (9 CENTIMETER), LEGE ARTIS. IN EACH CASE IN THREE STEPS, EVERY FOUR CENTIMETER FROM PROXIMAL TO DISTAL, DURING THE SIXTH AND LAST RADIOFREQUENCY ABLATION, THE ELECTRODE PARTIALLY DETACHED FROM THE SELF-EXPANDING BALLOON CATHETER AND WAS NOT REWRAPPED ONTO THE BALLOON UPON BALLOON DEFLATION, SO THAT THE ROLLED-UP ELECTRODE CAME TO LIE NEXT TO THE DEFLATED BALLOON. IMMEDIATELY AFTERWARD, SLIGHT OOZING BLEEDING OF THE ESOPHAGUS WAS OBSERVED, WHICH, HOWEVER, WAS NOT NECESSARILY ATTRIBUTABLE TO THE DYSFUNCTION, AS IT COULD ALSO BE EXPECTED PER SE AFTER TWICE-PERFORMED RADIOFREQUENCY ABLATION. THE CATHETER WAS CAREFULLY REMOVED FROM THE ESOPHAGUS TO RESOLVE THE ISSUE. THERE WAS NO EVIDENCE OF PERFORATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22337019 ↗
• InjuryMay 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS ALREADY PREPPED AND SEDATED INTRAVENOUSLY BUT THE BALLOON CATHETER DID NOT INFLATE AND AN AIR LEAK ERROR MESSAGE WAS DISPLAYED. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO USE A SECOND CATHETER BUT ALSO FAILED TO INFLATE. AFTER TWO CATHETERS WERE USED AND FAILED, THE THERAPY WAS STOPPED AND THE PATIENT WAS RESCHEDULED. THE PATIENT HAD UNDERGONE ADDITIONAL PROCEDURE WITH INTRAVENOUS SEDATION AND ENDOSCOPY.

  Patient problems: Insufficient Information

  MAUDE report 22015735 ↗
• InjuryMay 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS ALREADY PREPPED AND SEDATED INTRAVENOUSLY BUT THE BALLOON CATHETER DID NOT INFLATE AND AN AIR LEAK ERROR MESSAGE WAS DISPLAYED. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO USE A SECOND CATHETER BUT ALSO FAILED TO INFLATE. AFTER TWO CATHETERS WERE USED AND FAILED, THE THERAPY WAS STOPPED AND THE PATIENT WAS RESCHEDULED. THE PATIENT HAD UNDERGONE ADDITIONAL PROCEDURE WITH INTRAVENOUS SEDATION AND ENDOSCOPY.

  Patient problems: Insufficient Information

  MAUDE report 22015734 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TREATMENT FOR BARRETT'S ESOPHAGUS USING THE RADIOFREQUENCY ABLATION BALLOON CATHETER, THE PATIENT WAS ADMITTED WITH NAUSEA AND EXPERIENCED CHEST PAIN. THE PATIENT'S HOSPITALIZATION WAS EXTENDED DUE TO THESE EVENTS.

  Patient problems: Chest Pain; Nausea

  MAUDE report 21692528 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE TREATMENT USING THE RADIOFREQUENCY ABLATION BALLOON CATHETER, THE PATIENT, WHO WAS TREATED FOR BARRETT'S ESOPHAGUS, EXPERIENCED NAUSEA AND CHEST PAIN. THE PATIENT HAD TO BE ADMITTED AND DISCHARGED THE DAY AFTER THE PROCEDURE.

  Patient problems: Chest Pain; Nausea

  MAUDE report 21677942 ↗
• MalfunctionMar 6, 2025Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER FAILED TO INFLATE IN THE PATIENT. THERE WAS A DELAY IN EXAMINATION, DIFFICULTIES IN REMOVING THE PROBE TO THE PATIENT. THE CUSTOMER WAS ABLE TO REMOVE THE CATHETER FROM THE PATIENT SUCCESSFULLY, WITH NO ADVERSE EVENT. ANOTHER DEVICE WAS USED SUCCESSFULLY. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21533999 ↗
• MalfunctionFeb 25, 2025Difficult to Remove; Premature Separation; Difficult to Remove; Premature Separation

  IT WAS REPORTED THAT THE SPRING-TIPPED GUIDEWIRE WAS ADVANCED TO THE ANTRUM AND THE SCOPE WAS WITHDRAWN. THE CATHETER WAS ADVANCED OVER A WIRE AND ACROSS THE GE JUNCTION. TWO RADIOFREQUENCY ABLATIONS WERE PERFORMED. THE SCOPE WAS WITHDRAWN. THERE WAS MILD RESISTANCE REMOVING THE CATHETER AND WOUND WITHDRAWN, THE ABLATION COIL HAD DETACHED PARTIALLY FROM THE BALLOON. ON REPEAT INSPECTION, THERE WAS A SMALL MUCOSAL INJURY NOTED IN THE PROXIMAL ESOPHAGUS/UES REGION. THERE WAS SELF-LIMITED OOZING. THIS WAS CAREFULLY EXAMINED THE AID OF THE DISTAL ATTACHMENT CAP AND NO DEEP INJURY WAS SUSPECTED. GIVEN THIS FINDING, NO ADDITIONAL ABLATION WAS PERFORMED.

  Patient problems: Laceration(s)

  MAUDE report 21464329 ↗