LTV 18888-001Recalls & reported problems
Vyaire Medical, Inc. · LTV 1200 Ventilator, English · Class 2
All models of LTV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10190752115279), received between Sep 9, 2022 and Mar 20, 2026 — classified as 4 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem3
- Unexpected Shutdown3
- Failure to Power Up2
- Calibration Problem1
- Circuit Failure1
- Erratic or Intermittent Display1
- Failure to Cycle1
- Failure to Run on Battery1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Tidal Volume Fluctuations
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE DEVICE ALARMED FOR LOW EXHALED TIDAL VOLUME. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653560 ↗MalfunctionMar 13, 2026Intermittent Loss of Power
IT WAS REPORTED THAT THE DEVICE WAS INAPPROPRIATELY POWER CYCLING. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590437 ↗MalfunctionJan 9, 2026Failure to Power Up
CUSTOMER STATED THAT THE UNIT WILL NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020682 ↗MalfunctionOct 29, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR CIRCUIT DISCONNECTED WHILE ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412673 ↗MalfunctionOct 2, 2025Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE VENT IS NOT CYCLING, AND THE TURBINE IS NOT OPERATIONAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23199569 ↗MalfunctionSep 15, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT BEFORE USE, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23059327 ↗MalfunctionSep 11, 2025No Flow; No Flow
IT WAS REPORTED THAT DURING A PATIENT TRANSPORT THE DEVICE "STOPPED" WHILE IN USE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033548 ↗MalfunctionJul 16, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THE DEVICE POWERED OFF AND TURNED BACK ON WHEN A "BUMP" WAS ENCOUNTERED DURING TWO PATIENT TRANSPORTS. COMPLAINANT REPORTED CLINICAL STAFF SUCCESSFULLY RETURNED THE DEVICE TO AN OPERATING STATE AND COMPLETED THE PATIENT TRANSPORTS. COMPLAINANT REPORTED NO ADVERSE EFFECTS OR PATIENT HARM OCCURRED DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22518634 ↗MalfunctionJul 10, 2025Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469896 ↗MalfunctionJul 9, 2025Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT BEFORE USE, THE DEVICE EXPERIENCED A HARDWARE FAULT ERROR. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22457652 ↗MalfunctionJun 23, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
COMPLAINANT ALLEGED THAT THE DISPLAY IS FLICKERING AND APPEARS TO BE ATTEMPTING TO CYCLE POWER. THE DEVICE WAS TURNED OFF BY PRESSING AND HOLDING THE STANDBY/ON BUTTON FOR AN EXTENDED PERIOD. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT DURING THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 22312462 ↗MalfunctionMay 30, 2025Failure to Run on Battery; Failure to Run on Battery
COMPLAINANT ALLEGED THAT THE DEVICE WILL NOT RUN ON INTERNAL BATTERY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115793 ↗MalfunctionNov 20, 2024High Readings; High Readings
IT WAS REPORTED THE VENT TIDAL VOLUMES RETURNING MUCH HIGHER THAN SET. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734857 ↗InjuryOct 11, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENT WAS ON A PATIENT AND SUDDENLY STOPPED WORKING / SHUT OFF COMPLETELY. THE BATTERY WAS FULLY CHARGED. THERE WAS NO PATIENT HARM REPORTED, AS STAFF WAS NEAR THE PATIENT'S BEDSIDE DURING INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433368 ↗MalfunctionJul 5, 2024Circuit Failure; Circuit Failure
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR HAD INOP LIGHT ON WHILE DEVICE IS POWERED ON. DEVICE WAS NOT ON A PATIENT AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679504 ↗MalfunctionJun 18, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR'S INSP/EXP HOLD BUTTON WAS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558097 ↗InjuryJun 13, 2024Unintended System Motion; Unintended System Motion
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR WAS AUTO-CYCLING IN SIMV/CPAP MODE 10/6 ON A PATIENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT DEVICE NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19527823 ↗InjuryApr 26, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THE LTV VENTILATOR ""SHUT DOWN"" ON A PATIENT. THE RT'S REPORTED THAT IT SHUT DOWN AND THEY STATE IT DID NOT ALARM. THEY STATED THE PATIENTS O2 SATS WENT DOWN TO 37% WHEN THEY NOTICED IT. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19196436 ↗InjuryMar 28, 2024No Pressure; No Pressure
IT WAS REPORTED TO VYAIRE MEDICAL THE PRESSURE SUPPORT IS "NOT WORKING" ON THIS UNIT. THE UNIT WAS ON A PATIENT, NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992314 ↗MalfunctionSep 24, 2022Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAPTOP VENTILATOR SPRINTPACK BATTERY WAS NO LONGER CHARGING, AND THAT THE VENT INOPERABLE LIGHT WAS ON, THE CHARGE STATUS LIGHT WAS BLINKING ORANGE, AND NO LIGHTS CAME ON WHEN THE EXTERNAL BATTERY WAS TESTED. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481440 ↗MalfunctionSep 9, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR HAS BLENDER CLICKING WITH FIO2 ISSUE. THIS EVEN HAPPENED DURING PATIENT USE AND NO PATIENT HARM NOTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397161 ↗MalfunctionSep 9, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR HAS HARDWARE FAULT ALARM. THIS EVEN HAPPENED DURING PATIENT USE AND NO PATIENT HARM NOTED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15395889 ↗
Other Ventilator, continuous, facility use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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