LTV 21102-001 (UDI 10190752113770)Recalls & reported problems

Vyaire Medical, Inc. · LTV 1100 Ventilator, English · Class 2

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

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 10190752113770), received between Jan 26, 2024 and Jan 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pressure Problem” (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

Pressure Problem1

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.

MalfunctionJan 26, 2024Pressure Problem; Pressure Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1100 POSITIVE END-EXPIRATORY PRESSURE (PEEP) IS READING 0CMH2O NO MATTER WHAT IT IS SET TO. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18588056 ↗

Device details

UDI-DI	`10190752113770`
Brand	LTV
Model	21102-001
Company	Vyaire Medical, Inc.
Product code	CBK · Ventilator, continuous, facility use
Class	Class 2
FDA submission	K101643
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 12, 2022

Device type (GMDN): Transport electric ventilator

An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

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All Ventilator, continuous, facility use devices →

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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