ESOTEST MULTI PROBE 2617376H/USRecalls & reported problems

Fiab SPA · ESOTEST MULTI Probe is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 7 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature. · 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 08054953343884), received between Feb 10, 2021 and Feb 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Off-Label Use1

Patient problems

Gastroesophageal Burn1

Recent adverse event reports

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

InjuryFeb 10, 2021Off-Label Use; Off-Label Use
THE PHYSICIAN IDENTIFIED AN ESOPHAGEAL LESION, DESCRIBING IT A 'TRANSMURAL LESION' 2-3 WEEKS POST AN AF ABLATION PROCEDURE. THE RF ABLATION PROCEDURE WAS PERFORMED USING A BIOSENSE WEBSTER ABLATION AND MAPPING SYSTEM. THE ESOTEST MULTI PROBE WAS USED DURING THE PROCEDURE TO MONITOR ESOPHAGEAL TEMPERATURE.
Patient problems: Gastroesophageal Burn
MAUDE report 11310646 ↗

Device details

UDI-DI	`08054953343884`
Brand	ESOTEST MULTI PROBE
Model	2617376H/US
Company	Fiab SPA
Product code	FLL · Thermometer, Electronic, Clinical
Class	Class 2
FDA submission	K192210
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Dec 11, 2019

Device type (GMDN): Oesophageal temperature monitor probe

A sterile device inserted into the oesophagus and intended to be used to transmit oesophageal tissue temperature information to a connected oesophageal temperature monitor during left atrial cardiac ablation, to help prevent atrial-oesophageal fistula formation. It is typically constructed of flexible materials (e.g., polymers) and has a metal conducting core; it has multiple sensors at the distal end and a connector at the proximal end. It may have electrodes that are used for temporary transoesophageal stimulation if connected to a cardiac stimulator. This is a single-use device.

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