Level 1 MTS-40015Recalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 30695085000567), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryJan 30, 2026Material Separation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MYOCARDIAL TEMPERATURE SENSOR. DURING REMOVAL OF THE TEMPERATURE PROBE FROM THE TISSUE, THE METAL PORTION BROKE OFF AND REMAINED IN THE TISSUE. AN X-RAY WAS PERFORMED AFTER RETRIEVAL TO CONFIRM COMPLETE REMOVAL OF THE METAL FRAGMENT. THE ISSUE WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223183 ↗

Device details

UDI-DI	`30695085000567`
Brand	Level 1
Model	MTS-40015
Company	Icu Medical, Inc.
Product code	FLL · Thermometer, electronic, clinical
Class	Class 2
FDA submission	K920469
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 16, 2025

Device type (GMDN): General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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