LTV 1200 VENTILATORRecalls & reported problems across all models
Carefusion Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 362
- Deaths reported
- 10
- Injuries reported
- 76
- Recalls
- 0
We found 2 models of LTV 1200 VENTILATOR by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 362 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2018 and Dec 30, 2025 — classified as 10 deaths, 76 injuries, 276 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (252 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 1200 VENTILATOR problems
Device problems
- Mechanical Problem252
- Display or Visual Feedback Problem7
- Gas/Air Leak7
- Adverse Event Without Identified Device or Use Problem6
- Device Alarm System5
- Infusion or Flow Problem5
- Unexpected Shutdown5
- Battery Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions234
- No Information49
- No Patient Involvement35
- No Consequences Or Impact To Patient20
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Known Impact Or Consequence To Patient5
- Low Oxygen Saturation4
- Death3
LTV 1200 VENTILATOR models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LTV 1200 VENTILATOR 18888-001Ventilator, Continuous, Facility Use10 deaths323 reports
- LTV 1200 VENTILATOR 18888-201Ventilator, Continuous, Facility Use39 reports
Recent LTV 1200 VENTILATOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Device Alarm System; Device Alarm System
CUSTOMER STATED THAT THE UNIT ALARMED WITH A HARDWARE FAULT ERROR MESSAGE WHILE BEING USED ON A PATIENT BUT KEPT VENTILATING. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926757 ↗MalfunctionDec 24, 2025Device Alarm System; Device Alarm System
COMPLAINANT REPORTED WHILE POWERING ON, THE DEVICE SHOWED AN "INOP/HW" FAULT MESSAGE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888112 ↗MalfunctionDec 4, 2025Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS BEING TRANSPORTED INTO AN MRI ROOM, THEY OBSERVED THAT THE VENT WAS INDICATING AN HW FAULT ALARM. THEY SECURED THE PATIENT IN A BAG, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER LTV. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718156 ↗MalfunctionJul 2, 2025Failure to Run on Battery; Failure to Run on Battery
COMPLAINT ALLEGED THAT BEFORE USE, THE DEVICE INAPPROPRIATELY SHUT DOWN WHEN UNPLUGGED. COMPLAINT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384882 ↗MalfunctionJan 6, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE FIO2 WAS NOT REACHING 60%.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21081362 ↗MalfunctionJul 12, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE O2 BLENDER IS DEFECTIVE DUE TO THE FIO2 READINGS. HE REPLACED THE BLENDER AND IT RESOLVED THE ISSUE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730411 ↗InjuryJun 10, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 VENT REPEATED SHUTDOWN AND STARTS-UP WHILE IT WAS WORKING ON PATIENT. THE VENT STARTED JUST AFTER IT WAS TURNED ON, BUT SHUTDOWN RIGHT AWAY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19504974 ↗InjuryMay 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DEVICE WAS PULLED INTO THE MRI. PATIENT WAS INVOLVED BUT NO PATIENT HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392238 ↗MalfunctionApr 22, 2024Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED TO VYAIRE MEDICAL THAT SOME LED NUMBERS LIGHT UP WRONG IN THE VTE READINGS AND OTHER RESULTS ON THE DISPLAY. FOUND WHEN PERFORMING A 10K PM SO THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19153950 ↗MalfunctionMar 14, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT UPON STARTUP THE CONNECTOR THAT GOES INTO THE O2 TRANSDUCER ON ANALOG BOARD COMES OFF WHEN O2 IS PLUGGED INTO THE UNIT CAUSING IT TO LEAK. CUSTOMER CAN'T GET THE SW VERSION AT THE MOMENT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909238 ↗MalfunctionMar 14, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO THE VYAIRE MEDICAL THAT THE VENT IS FAILING THE LEAK TEST AND IS GETTING A LEAK OF 4.1. THE REPORTER PERFORMED A LEAK TEST WITH THE VENT OPEN AND DOES NOT FEEL ANY LEAKS ANYWHERE AND DOUBLE CHECKED THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18903453 ↗InjuryJan 31, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 WON'T VENTILATE WHEN CONNECTED TO THE PATIENT. THE UNIT WAS SWAPPED OUT AND THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617186 ↗MalfunctionJan 31, 2024Activation Failure; Activation Failure
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR INOPERABLE ALARM OCCURRED ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18613407 ↗InjuryJan 18, 2024Smoking; Smoking
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 HAD A BURNING SMELL AND FELT 'OVERHEATED.' NOTICED A CLICKING SOUND COMING FROM THE SOLENOID MOUNT DURING EACH BREATH, WHETHER THE DEVICE WAS OPEN OR CLOSED. THE UNIT WAS ON A PATIENT AT THE TIME OF THE BURNING SMELL ISSUE, BUT NO PATIENT HARM WAS REPORTED. THEY SWAPPED OUT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18538286 ↗MalfunctionJan 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO VYAIRE MEDICAL THAT CUSTOMER REQUESTED DOWNLOAD AND ANALYSIS OF THE EVENT TRACE DURING USE ON A PATIENT ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18528141 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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