Barrx 1190A-230A (UDI 10884521786035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521786035), received between Aug 21, 2024 and Sep 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Power 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.

• InjurySep 11, 2025Power Problem; Power Problem

  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 23031144 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED A MAJOR BLEED FOLLOWING RADIO FREQUENCY ABLATION TREATMENT ON THE (B)(6) PRESENTED TO HOSPITAL WITH C/O VOMITING BLOOD (ABOUT 1 PINT) A WEEK AFTER HAVING HALOTHERAPY. ALSO, C/O FEELING SHORT OF BREATH AND BEING NAUSEOUS, WITH SOME EPIGASTRIC PAIN, AND HAVING BLACK STOOLS. ON EXAMINATION HE WAS QUITE PALE, AND HEMODYNAMICALLY UNSTABLE. PATIENT WAS RESUSCITATED WITH BLOOD AND PLASMA TRANSFUSION AND WAS TREATED WITH IV PPI AND WAS TAKEN FOR URGENT OGD, WHICH SHOWED A LARGE UGI BLEED SECONDARY TO ULCER, AND WAS ENDO-CLIPPED. TWO DAYS POST-OPERATIVE, THE PATIENT WAS ADMITTED TO A LOCAL HOSPITAL¿S INTENSIVE THERAPY UNIT WITH A MAJOR BLEED. THE PATIENT UNDERWENT ANOTHER RADIO FREQUENCY ABLATION ON THE (B)(6) TO TREAT BARRETT'S OESOPHAGUS AND DEVELOPED ANOTHER MAJOR BLEED ON THE (B)(6), LEADING TO ANOTHER HOSPITAL ADMISSION. AS OF THE (B)(6), THE PATIENT WAS STILL IN THE INTENSIVE THERAPY UNIT. NOTHING ABNORMAL WAS NOTED DURING THE RADIO FREQUENCY ABLATION OR IMMEDIATELY AFTER THE PROCEDURE. A NEW CATHETER WAS USED FOR EACH ABLATION. THE TECHNIQUE USED TO ABLATE THE TISSUE WAS (B)(6) 2024 C10 M10 30-40 CM TREATED WITH CIRCUMFERENTIAL (APP, S

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 20022713 ↗