EsoFLIP ES-320Recalls & reported problems
Covidien LP · Endolumenal Functional Lumen Imaging Probe · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521809444), received between Jun 29, 2022 and Jun 29, 2022 — classified as 1 injury.
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
- Perforation of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PATIENT HAD PARTIAL PERFORATION. THE PATIENT WAS TREATED WITH AN ESOPHAGEAL STENT AND DID WELL. THE PATIENT HAD ALSO BEEN DIAGNOSED WITH EOSINOPHILIC ESOPHAGITIS (EOE).
Patient problems: Perforation of Esophagus
MAUDE report 14854252 ↗
Other esophageal dilator with balloon and electrode sensors devices
- EsoFLIP ES-330Covidien LP · Esophageal Dilator With Balloon And Electrode Sensors8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.