LTVRecalls & reported problems across all models
Carefusion Corporation · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 8 models of LTV by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2019 and Apr 16, 2024 — classified as 10 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (69 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 Problem69
- Tidal Volume Fluctuations6
- Improper Flow or Infusion4
- Infusion or Flow Problem4
- Battery Problem3
- Display or Visual Feedback Problem2
- Reset Problem2
- Unexpected Shutdown2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Information32
- No Patient Involvement18
- No Consequences Or Impact To Patient5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Low Oxygen Saturation1
LTV models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LTV 10130Ventilator, Continuous, Facility Use43 reports
- LTV 18888-006Ventilator, Continuous, Facility Use43 reports
- LTV 18984-006Ventilator, Continuous, Facility Use3 reports
- LTV 18881-001Ventilator, Continuous, Facility Use2 reports
- LTV 10130JVentilator, Continuous, Facility Use2 reports
- LTV 18888-008Ventilator, Continuous, Facility Use2 reports
- LTV 18888-003Ventilator, Continuous, Facility Use1 report
- LTV 21102-001Ventilator, 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.
MalfunctionApr 16, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED TO VYAIRE THAT THE LTV 1200 VENT RESTARTED ITSELF PRIOR TO USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19119043 ↗MalfunctionJan 9, 2024Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1200 VENTILATOR BLENDER WAS FAILING DURING PM (PREVENTIVE MAINTENANCE) DUE TO INACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN). THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18481013 ↗InjuryJun 20, 2022Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR SHUT OFF WHILE ON PATIENT DURING TRANSPORT, BUT NO HARM ASSOCIATED WITH THE REPORTED EVENT. THE END USERS WERE NOT USING AN EXTERNAL BATTERY PACK AND THE ASSUMPTION IS THE INTERNAL BATTERY DIED. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE UNIT GOT PLUGGED IN AS SOON AS THE USER SAW IT WAS NOT CHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14750055 ↗MalfunctionMay 14, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 HAS HIGH PRESSURE SENSE LINE LEAKS AND BROKEN ACCUMULATOR. 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 14403387 ↗MalfunctionMay 12, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH LAP TOP VENTILATOR 1200 WHERE SOME LED DOTS ARE DARK. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14383467 ↗MalfunctionMay 12, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH LAP TOP VENTILATOR 1200 WHERE SOME LED DOTS ARE DARK. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14382896 ↗MalfunctionMar 1, 2022Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR SHUTDOWN WHILE ON A TRANSPORT, BUT INDICATED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13640875 ↗MalfunctionMar 1, 2022Unexpected Shutdown; Unexpected Shutdown
THE CUSTOMER REPORTED DEVICE SHUT DOWN WHILE ON A TRANSPORT ON THE LAP TOP VENTILATOR 1000. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13640498 ↗MalfunctionNov 24, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR WAS HAVING FIO2 INACCURACY. 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 12872662 ↗MalfunctionOct 7, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1000 HAS LEAK AT LOWER PORT ON SOLENOID MANIFOLD. 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 12594863 ↗MalfunctionAug 24, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LTV VENTILATOR PART OF LED WAS DARK. THIS IS FRONT PANEL OVERVIEW - CONTROL SECTION. BREATH RATE. INSP TIME. O2%. SENSITIVITY AND PEEP. 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 12363396 ↗MalfunctionAug 13, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED LN VENT OCCURRED IN THIS DEVICE. THERE IS PATIENT INVOLVEMENT ASSOCIATED WITH THE ISSUE REPORTED BUT NO HARM HAPPENED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12319714 ↗MalfunctionJul 20, 2021Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR OXYGEN READING WAS 90% WHEN SET AT 100% AND THE TURBINE WAS FOUND TO BE LEAKING. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12200230 ↗MalfunctionApr 23, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 HAS CONTINUOUS HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) ALARM. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712878 ↗MalfunctionApr 19, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1000 EXPERIENCED DISCONNECT ALARM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11690619 ↗
Other Carefusion Corporation products
All Carefusion Corporation 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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