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LTV 2200 VENTILATOR 22690-001Recalls & reported problems

Vyaire Medical, Inc. · LTV2 2200 Ventilator · Class 2

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

Quick summary

The LTV 2200 ventilator from Vyaire Medical is a portable machine used to keep patients breathing. The 27 reports mostly describe hardware and mechanical trouble — loud fan or turbine noise, false fault and "check circuit" alarms, gas leaks, and oxygen blender readings that drift or read low, plus display screen failures. Six reports involve injuries; no deaths are described. There are no recalls naming this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
27
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10190752139220), received between Apr 12, 2021 and Nov 21, 2025 — classified as 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (16 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: 9 reportsDec 2023: 0 reportsJan 2024: 4 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 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 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem16
  • Incorrect Measurement4
  • Connection Problem1
  • Display or Visual Feedback Problem1
  • Failure to Calibrate1
  • Gas/Air Leak1
  • Noise, Audible1
  • Overfill1

Patient problems

  • No Clinical Signs, Symptoms or Conditions26
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 21, 2025Connection Problem; Connection Problem

    IT WAS REPORTED THAT DURING USE ON A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE EXPERIENCED A CONSISTENT HARDWARE FAULT ALARM. IT WAS CONFIRMED THAT THE DEVICE CONTINUED TO VENTILATE DURING THE REPORTED ALARM. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23623831 ↗
  • MalfunctionMar 24, 2025Failure to Calibrate; Failure to Calibrate

    COMPLAINANT ALLEGED THAT THE DEVICE IS OVER TRIGGERING WITH A "CHECK CIRCUIT " ALARM MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Patient problems: Insufficient Information

    MAUDE report 21678934 ↗
  • MalfunctionOct 16, 2024Overfill; Overfill

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE FAN AND TURBINE WAS REPLACED, BUT THE TURBINE SOUND IS STILL THERE. THE SOUND IS COMING FROM THE TURBINE INPUT AS A BACK FLOW. NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20464627 ↗
  • InjuryAug 28, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT SUDDENLY THE UNIT STARTED HAVING DEAD PIXELS ON THE LED. THE DEVICE WAS ON A PATIENT AT THE TIME OF THE ISSUE. NO PATIENT HARM WAS REPORTED. UNIT WAS REMOVED FROM PATIENT DUE TO ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20092000 ↗
  • InjuryApr 26, 2024Noise, Audible; Noise, Audible

    IT WAS REPORTED TO VYAIRE MEDICAL THAT "SUDDENLY THE UNIT STARTED HAVING HIGH FAN NOISE WHILE ON PATIENT WHICH WORRIED THE USER OF A FAULT OR OVERHEATING WHICH RESULTED IN REMOVING THE UNIT. THE UNIT IS NEW WITH MINIMUM USAGE." SWAPPED OUT DEVICE FOR DIFFERENT UNIT. NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19193452 ↗
  • MalfunctionApr 9, 2024Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV2 VENTILATOR AND THE BLENDER IS NOT WORKING PROPERLY ANYMORE. LOW FOI2 READINGS. WHEN SETTING O2 AT 100% THE UNIT GIVES MAX OF 70% FIO2 TOGETHER WITH THE IMT AND ALL THE OTHER READINGS ARE OUT. TRIED CALIBRATION OF THE O2 INLET BUT WE COULDN'T RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19071890 ↗
  • MalfunctionJan 12, 2024Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 TIDAL VOLUMES ARE READING IN THE 2000 TO 3000 RANGE. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18503923 ↗
  • MalfunctionJan 11, 2024Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 O2 BLENDING PERCENTAGE HAD FAILED AT 90%.THE RESULT WAS 96.1% WHILE THE MAXIMUM SPECIFICATION IS 95%. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18499832 ↗
  • MalfunctionJan 11, 2024Incorrect Measurement; Incorrect Measurement

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 VTI (INHALED TIDAL VOLUME) TEST FAILED. THE CALCULATED MINIMUM SPECIFICATION WAS 265 BUT THE RESULT WAS 245. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18493701 ↗
  • MalfunctionJan 4, 2024Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 220 HAS HIGH SIDE/LOW SIDE LEAK FAILURE. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18446478 ↗
  • MalfunctionNov 2, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT FRACTION OF INSPIRED OXYGEN VIA EXTERNAL ANALYZER WAS MUCH LOWER THAN THE FRACTION OF INSPIRED OXYGEN THAT WAS SET ON THE LAP TOP VENTILATOR 2200. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18055650 ↗
  • MalfunctionNov 2, 2023Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 2200 VENTILATOR IN WHICH THE FIO2 (FRACTION OF INSPIRED OXYGEN) VIA EXTERNAL ANALYZER WAS MUCH LOWER THAN THE FIO2 THAT WAS SET ON THE VENT. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18055534 ↗
  • InjuryNov 2, 2023Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 2200 VENTILATOR IN WHICH THE FIO2 (FRACTION OF INSPIRED OXYGEN) VIA EXTERNAL ANALYZER WAS MUCH LOWER THAN THE FIO2 THAT WAS SET ON THE VENT DURING PATIENT USE. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT. UNIT WAS SWAPPED OUT FOR A DIFFERENT DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18055442 ↗
  • MalfunctionNov 2, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT FRACTION OF INSPIRED OXYGEN VIA EXTERNAL ANALYZER WAS MUCH LOWER THAN THE FRACTION OF INSPIRED OXYGEN THAT WAS SET ON THE LAP TOP VENTILATOR 2200. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18055374 ↗
  • InjuryNov 2, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 VENTILATOR FIO2 VIA EXTERNAL ANALYZER WAS MUCH LOWER THAN THE FIO2 WAS SET. THIS HAPPENED DURING PATIENT USE. THE VENTILATOR WAS SWAPPED OUT FOR A DIFFERENT DEVICE. THERE WAS NO PATIENT HARM REPORTED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18055325 ↗
  • MalfunctionNov 1, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT TIDAL VOLUME INSPIRED (VTI) WAS MEASURED TO BE BELOW THE ACCEPTABLE RANGE ON THE LAP TOP VENTILATOR 2200. 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 18049631 ↗
  • MalfunctionNov 1, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 VTI (INHALED TIDAL VOLUME) WAS MEASURED AT 255 ML, WHICH WAS BELOW THE PASSING RANGE OF 265-335 ML. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18049498 ↗
  • MalfunctionNov 1, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 2200 VTI (INHALED TIDAL VOLUME) WAS MEASURED TO BE 252 ML, BELOW THE ACCEPTABLE RANGE OF 265-335 ML. AS OF THIS TIME, THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18049329 ↗
  • MalfunctionNov 1, 2023Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO VYAIRE MEDICAL THAT TIDAL VOLUME INSPIRED (VTI) WAS MEASURED TO BE BELOW THE ACCEPTABLE RANGE ON THE LAP TOP VENTILATOR 2200. 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 18048991 ↗
  • InjuryMay 4, 2022Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED THE PRESSURE ON THIS UNIT KEPT RISING, THEN WOULD DUMP AND BACK AND FORTH DURING USE ON A PATIENT ON THE LAP TOP VENTILATOR 2200. THE CUSTOMER REPORTED THE UNIT WAS SWAPPED OUT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14281037 ↗
  • InjuryApr 13, 2022Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE PEEP (POSITIVE END-EXPIRATORY PRESSURE) KEPT DROPPING OUT AND THEN COMING BACK UP CONSTANTLY ON THE LTV 2200 LAP TOP VENTILATOR DURING PATIENT USE. THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR AND THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14107468 ↗
  • MalfunctionJan 10, 2022Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 2200 VENTILATOR WAS HAVING CONTINUOUS CHECK CIRCUIT ISSUE. 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 13213186 ↗
  • MalfunctionDec 30, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT LTV 2200 VENTILATOR IS CONTINUOUSLY ALARMING "CHECK CIRCUIT". THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND THE REPORTED ISSUE OCCURRED DURING SET-UP BEFORE PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13119452 ↗
  • MalfunctionNov 23, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 2200 ALARMED CHK (CHECK) CIRCUIT. THE PEEP (POSITIVE END EXPIRATORY PRESSURE) AND INSPIRATORY PRESSURE ARE NOT ACCORDING CONTROL. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12860559 ↗
  • MalfunctionNov 23, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 2200 ALARMED CHK (CHECK) CIRCUIT. THE PEEP (POSITIVE END EXPIRATORY PRESSURE) AND INSPIRATORY PRESSURE ARE NOT ACCORDING CONTROL. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12860522 ↗

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Sources and updates

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