LTVRecalls & reported problems across all models
Vyaire Medical, Inc. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 9 models of LTV by Vyaire Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2021 and Mar 31, 2026 — classified as 10 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LTV problems
Device problems
- Mechanical Problem11
- Unexpected Shutdown3
- Defective Device2
- Device Alarm System2
- Failure to Power Up2
- Calibration Problem1
- Circuit Failure1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Increased Respiratory Rate2
- Insufficient Information2
- Decreased Respiratory Rate1
LTV models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LTV 18888-001Ventilator, continuous, facility use22 reports
- LTV 29657-001Ventilator, continuous, facility use9 reports
- LTV 10130Ventilator, continuous, facility use5 reports
- LTV 19222-201Ventilator, continuous, facility use2 reports
- LTV 21102-001Ventilator, continuous, facility use1 report
- LTV 29663-001Ventilator, continuous, facility use1 report
- LTV 15090-104Ventilator, continuous, facility use1 report
- LTV 17475-001Ventilator, continuous, facility use1 report
- LTV 24555-001Ventilator, continuous, facility use1 report
Recent LTV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Device Alarm System; Gas Output Problem
IT WAS REPORTED THAT DURING USE ON A 55-YEAR-OLD FEMALE, THE CIRCUIT CAUSED THE VENTILATOR TO INAPPROPRIATELY SET OFF AN ALARM AND CAUSED RAPID TRIGGERING, NOT ALLOWING THE PATIENT TO TAKE NORMAL BREATHS. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. THE CUSTOMER'S REPORT IS AGAINST TWO CIRCUITS FROM THE SAME LOT NUMBER AND IT IS NOTED THAT THE CIRCUITS WERE DISPOSED OF AND ARE NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24746817 ↗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 18, 2026Mechanical Problem
IT WAS REPORTED THAT ONCE IN USE, THE PATIENT STATED THAT THE CIRCUIT APPEARED TO CAUSE THE VENTILATOR TO MALFUNCTION, RESULTING IN RAPID TRIGGERING AND PREVENTING THE PATIENT FROM TAKING NORMAL BREATHS. BOTH CIRCUITS WITH MATCHING LOT NUMBER 0004309572 PRODUCED THE SAME VENTILATOR RESPONSE. THE PATIENT REPLACED THE CIRCUITS WITH A BACKUP CIRCUIT OF THE SAME ITEM ID (29657001) BUT A DIFFERENT LOT NUMBER, AFTER WHICH THE VENTILATOR CEASED RAPID TRIGGERING. THE PATIENT REPORTED THAT THE VENTILATOR HAD NOT EXHIBITED SIMILAR ISSUES PREVIOUSLY. NO HARM WAS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT DISCARDED THE CIRCUITS AFTER THE EVENT.
Patient problems: Decreased Respiratory Rate
MAUDE report 24627606 ↗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 ↗
Other Vyaire Medical, Inc. products
All Vyaire Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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