SENSITHERM MULTI ST-PROBE-7Recalls & reported problems
Fiab SPA · ST-PROBE-7 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 08058480753994), received between Oct 7, 2024 and Oct 7, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Laceration(s) of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FIAB S.P.A. RECEIVED A COMPLAINT REPORT FROM THE US DISTRIBUTOR ABOUT THE ESOPHAGEAL TEMPERATURE PROBE MODEL ST-PROBE-7 THE TEMPERATURE PROBE IS PLACED INTO PATIENT'S ESOPHAGUS BEFORE STARTING MEDICAL PROCEDURES THAT MAY IMPLY TEMPERATURE VARIATIONS, THE EVENT WAS ASSESSED BY FIAB AS A REPORTABLE EVENT ACCORDING TO THE DESCRIPTION PROVIDED BY THE DISTRIBUTOR, WHOSE FIELD REPRESENTATIVE WAS PRESENT IN THE EP ROOM DURING THE MEDICAL PROCEDURE: "AS THE CATHETERS WERE BEING REMOVED FROM THE BODY, THE CRNA NOTIFIED THAT THERE WAS A SUBSTANTIAL AMOUNT OF BLEEDING COMING FROM SOME UNKNOWN PLACE. THE CRNA WAS SUCTIONING THE BLOOD FROM THE PATIENT'S MOUTH. THERE WAS A SENSITHERM ESOPHAGEAL TEMPERATURE CATHETER IN PLACE AND IT WAS NOTED THAT THERE WERE SEVERAL ATTEMPTS AT THE BEGINNING OF THE PROCEDURE TO PLACE THE SENSITHERM CATHETER IN THE CORRECT LOCATION.THE CRNA REPOSITIONED THE CATHETER. I DID NOT WITNESS HER USING ANY LUBRICATION ON THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, SHE USED THE INTUBATION BLADE TO HELP GUIDE HER VISUALLY AND THE CATHETER WAS SUCCESSFULLY PLACED IN A GOOD POSITION VERIFIED BY ELECTROGRAM SIGNALS. THE PATIENT HAD A NASAL SCOPE DONE BEFORE LEAVING THE P
Patient problems: Laceration(s) of Esophagus
MAUDE report 20385691 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.