Barrx 1190A-230A (UDI 10884521181281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521181281), received between May 13, 2025 and Sep 2, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVE A RADIO FREQUENCY ABLATION, AFTER DILATING THE ESOPHAGUS A STRICTURE AREA REMAINS. IT WAS ALSO REPORTED THAT THE PATIENT HAD EXPERIENCED SEVERE ESOPHAGEAL INFLAMMATION, PAIN AND SYSTEMIC REACTION WITH ELEVATED C-REACTIVE PROTEIN (CRP) AND PLEURAL EFFUSIONS. THE PATIENT WAS ADMITTED ACUTELY AND MEDICAL INTERVENTION WAS PERFORMED.

  Patient problems: Inflammation; Pain; Pleural Effusion

  MAUDE report 22939256 ↗
• InjuryMay 13, 2025Leak/Splash; Leak/Splash

  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 22015737 ↗