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LTV 1200 VENTILATOR 18888-201 (UDI 10190752115637)Recalls & reported problems

Vyaire Medical, Inc. · LTV 1200 Ventilator, MRI Conditional, English · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
10
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10190752115637), received between May 18, 2022 and Aug 4, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 2 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem2
  • Pressure Problem2
  • Failure to Run on Battery1
  • Failure to Sense1
  • Low Readings1
  • Noise, Audible1
  • Power Problem1
  • Volume Accuracy Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9
  • Insufficient Information1

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 4, 2025Failure to Sense; Failure to Sense

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE BREATH RATE FUNCTION OF THE DEVICE. THERE WAS NO MENTION OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22703527 ↗
  • MalfunctionJul 1, 2025Noise, Audible; Noise, Audible

    COMPLAINTANT ALLEGED THAT BEFORE USE, THE DEVICE WAS EXPERIENCING A CLICKING NOISE NEAR THE O2 INLET. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22370619 ↗
  • MalfunctionJul 11, 2024Failure to Run on Battery; Failure to Run on Battery

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR FAILED DURING USE. IT SHUT OFF AND GAVE CODE ""BATT INOP ERROR". UNKNOWN PATIENT STATUS. RECEIVED MEDWATCH REPORT FROM COMPLAINT TEAM.

    Patient problems: Insufficient Information

    MAUDE report 19721364 ↗
  • InjuryJun 27, 2024Low Readings; Low Readings

    IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER REPORTED LOW O2 PRESS ALARM WHILE VENT WAS ON PATIENT. THE CUSTOMER REPORTED THAT PATIENT DESATURATED BUT WAS NOT INJURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19629676 ↗
  • MalfunctionNov 27, 2023Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR A PERSISTENT O2 (OXYGEN) PRESSURE LOW ALARM. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18208784 ↗
  • MalfunctionNov 24, 2023Volume Accuracy Problem; Volume Accuracy Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT A HIGH POSITIVE END-EXPIRATORY PRESSURE (PEEP) ALERT WHEN THE LTV 1200 IS SET TO 5, AND EVEN AT 2, AND THE TEST LUNGS APPEAR TO BE ABOUT TO RUPTURE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18205904 ↗
  • MalfunctionSep 12, 2023Power Problem; Power Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT CONSTANT POWER LOSS OCCURRED ON THE LAP TOP VENTILATOR 1200. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17731287 ↗
  • MalfunctionJan 31, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR ALARMED HW FAULT DURING PATIENT USE WHILE IN THE MRI. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16275559 ↗
  • InjuryJan 30, 2023Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE UNIT WAS ALARMING LOW BATTERY WITH A RED BATTERY CHARGE LEVEL INDICATOR DURING PATIENT USE IN THE MRI. FURTHERMORE, THE PATIENT WAS QUICKLY VENTILATED MANUALLY AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16268053 ↗
  • InjuryMay 18, 2022Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEMS WITH LAP TOP VENTILATOR 1200. THE RESPIRATORY THERAPIST NOTED A HIGH PRESSURE READING, BUT INACCURATE. THE VENT IS ALSO DUE FOR PM. FURTHERMORE, THE CUSTOMER CONFIRMED THAT ALTERNATIVE VENTILATION WAS PROVIDED TO THE PATIENT. RESPIRATORY THERAPIST WAS ABLE TO SWITCH THE VENTILATOR AND THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14432075 ↗

Other Ventilator, continuous, facility use devices

All Ventilator, continuous, facility use devices →

Sources and updates

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