Barrx TTS-1100 (UDI 10884521176621)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521176621), received between Mar 14, 2019 and May 12, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE PERFORMING RADIOFREQUENCY ABLATION AT 48 WATTS AND 12 JOULES, AN EPISODE OF SINUS ARRHYTHMIA WAS NOTED. IMMEDIATE STABILIZATION PROTOCOLS WERE FOLLOWED TO WHICH THE ANESTHESIOLOGIST ADMINISTERED MAGNESIUM, LIDOCAINE, ESMOLOL, AND BUTYL HYOSCINE, ALLOWING FOR THE COMPLETION OF THE PROCEDURE. POST-PROCEDURAL EVALUATION CONFIRMED THE PATIENT WAS STABLE. THERE WERE NO LOOSE COMPONENTS.

  Patient problems: Arrhythmia

  MAUDE report 25149989 ↗
• InjuryApr 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON REMOVAL, THE TIP OF A DEVICE BROKE OFF IN THE ESOPHAGUS. THE BROKEN TIP WAS RETRIEVED VIA BIOPSY FORCEPS. THE SAME DEVICE WAS USED TO COMPLETE THE ABLATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21866301 ↗
• InjuryDec 29, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A PORTION OF THE ABLATION CATHETER WAS STUCK IN THE PATIENT'S MUCOSA AND AS IT WAS MANIPULATED, THE CATHETER TORE. A SNARE WAS USED TO RETRIEVE THE STUCK ELECTRODE. THE PATIENT WAS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18422609 ↗
• InjuryOct 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER BROKE OFF INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE CATHETER FROM THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17981042 ↗
• MalfunctionJun 28, 2023Material Twisted/Bent

  CHANNEL RFA (RADIO FREQUENCY ABLATION) CATHETER WOULD NOT GO THROUGH THE SCOPE WORKING CHANNEL. THE TYPE OF CATHETER USED WAS THE BARRX CHANNEL RFA ENDOSCOPIC CATHETER. NEVER HEARD OF AN ISSUE WITH THIS PARTICULAR INSTRUMENT BEFORE THIS OCCURRENCE. DOCTOR AND THE SURGICAL TECHNOLOGIST IN THE ROOM TRIED MULTIPLE ROUTES OF GETTING DOWN THE WORKING CHANNEL, AND WHEN IT WAS EVENTUALLY INTRODUCED INTO THE ESOPHAGUS, IT WAS BENT AND NOT WORKING PROPERLY. THE TISSUE ABLATIONS WERE NOT 100% BECAUSE THE TISSUE WAS NOT GETTING THE FULL CONTACT OF THE PADDLE. THE FAULTY CATHETER WAS TAKEN OUT OF THE PATIENT AND A NEW ONE WAS USED AND HAD NO DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216046 ↗
• 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 9112619 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, A WEEK POST INLET PATCH RADIO FREQUENCY ABLATION PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THROAT PAIN AND DYSPHAGIA. THE PATIENT WAS GIVEN PAIN REVILER BOTH ORALLY AND INTRAVENOUSLY AND PLACED ON LIQUID DIET TO REGULATE THE PAIN AND DYSPHAGIA. THE CUSTOMER NOTED THAT THERE WERE NO ERROR CODES FLAGGED DURING THE PROCEDURE. THE PHYSICIAN WAS NOT ATTRIBUTING THE HOSPITALIZATION TO THE DEVICE AND WAS CONFIDENT THAT IT WAS DUE TO THE PROCEDURE. THE PATIENT'S THROAT PAIN AND DYSPHAGIA WERE RESOLVED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Dysphagia/ Odynophagia; Sore Throat

  MAUDE report 8422947 ↗