Barrx TTS-1100 (UDI 10884521581753)Recalls & reported problems
Covidien LP · Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications · Class 2
All models of Barrx (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521581753), received between Jul 24, 2025 and Sep 2, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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.
Reports received per month
Most reported problems
Device problems
- Device Displays Incorrect Message1
- Difficult to Remove1
- Insufficient Device Problem Information1
- Smoking1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564664 ↗InjuryNov 21, 2025Smoking; Sparking; Insufficient Device Problem Information; Smoking; Sparking; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING RADIO FREQUENCY ABLATION (RFA) PROCEDURE FOR SQUAMOUS INTRAEPITHELIAL NEOPLASIA, THE CATHETER ELECTRODE SPARKED UNDER ENDOSCOPY, AT THE ABLATION ELECTRODE SITE, AND SMOKE WAS OBSERVED. THE LEAD WAS REMOVED AND SURGERY WAS STOPPED. AFTER THE ELECTRODE WAS WITHDRAWN, DAMAGE WAS OBSERVED ON THE ELECTRODE SURFACE. THERE WAS NO PATIENT OR USER HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23616839 ↗InjuryJul 24, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE FOR THE TREATMENT OF RADIATION PROCTITIS, THE CATHETER DID NOT ACTIVATE. IT DISPLAYED AN E92 ERROR MESSAGE AND INSTRUCTED TO CLEAN THE PROBE AND RESET THE MACHINE. IT WAS CLEANED AND THE MACHINE WAS RESTARTED TWICE AS INSTRUCTED BY THE MACHINE. THE PATIENT HAD SEDATION AND ENDOSCOPY DURING THE INITIAL PROCEDURE AND WAS BROUGHT BACK THE NEXT DAY TO COMPLETE THE TREATMENT WITH ANOTHER CATHETER AND ALSO REQUIRED SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584765 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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