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Barrx GW-002BRecalls & reported problems

Covidien LP · RFA Endoscopic Guidewire · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521189454), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Laceration(s) of Esophagus1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A RADIO FREQUENCY ABLATION OF BARRETT'S ESOPHAGUS FOLLOWING A BALLOON ABLATION OF A PROXIMAL SEGMENT OF ESOPHAGUS, THERE WAS A BLEEDING ON THE 9:00 WALL OF THE ESOPHAGUS. AFTER SUCCESSFULLY REMOVING THE CATHETER WITHOUT INCIDENT, THE PHYSICIAN IRRIGATED AND INSPECTED THE BLEEDING AREA AND THERE APPEARED TO BE AN ESOPHAGEAL TEAR ON THE 9:00 WALL OF THE ESOPHAGUS. AFTER CONTINUED INSPECTION AND IRRIGATION, THE BLEEDING STOPPED. IT WAS DETERMINED THAT HEMOCLIPS WERE NOT NEEDED. THE PHYSICIAN DECIDED TO DISCONTINUE THE PROCEDURE.

    Patient problems: Laceration(s) of Esophagus; No Code Available

    MAUDE report 8466944 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.