AVEA 2 VENTILATOR 32029-001Recalls & reported problems

Vyaire Medical, Inc. · AVEA VENTILATOR · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Vyaire AVEA ventilator is a breathing machine for facility use. Its 300 reports mostly describe mechanical problems, along with screens going black, oxygen alarms going off and a breathing circuit blockage during use. The reports include 1 death and 35 injuries. No recalls name 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: 300
Deaths reported: 1
Injuries reported: 35
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 10846446066074), received between Dec 2, 2019 and Jul 18, 2024 — classified as 1 death, 35 injuries, 264 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (212 reports).

15 other recalls cover devices cleared under the same FDA submission (K103211); they may or may not involve this specific model.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Mechanical Problem212
Display or Visual Feedback Problem17
Leak/Splash9
No Display/Image5
Tactile Prompts/Feedback5
Device Alarm System4
High Readings4
Infusion or Flow Problem4

Patient problems

No Clinical Signs, Symptoms or Conditions277
No Patient Involvement12
Low Oxygen Saturation5
No Information4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 300 reports, in the reporter's own words as published by the FDA.

InjuryJul 18, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL: THE AVEA VENTILATOR HAD INOP ERROR WHILE ON A PATIENT. THE PATIENT REQUIRED MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19773351 ↗
MalfunctionJun 5, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR SCREEN TURNED BLACK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19469280 ↗
MalfunctionJun 4, 2024High Readings; High Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA II FAILED TO BE IN SPEC. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19464023 ↗
MalfunctionMay 22, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL, THE AVEA VENTILATOR IS GIVING LOW O2 ALARM. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19376920 ↗
MalfunctionMay 22, 2024High Readings; High Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENT IS GIVING HIGH O2 ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19373788 ↗
MalfunctionMay 22, 2024High Readings; High Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT HIGH FRACTION OF INSPIRED OXYGEN OCCURRED ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19370770 ↗
MalfunctionMay 20, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL A CIRCUIT OCCLUSION OCCURRED WHILE ON A PATIENT, RESULTED IN HIGH PPEAK. CURRENTLY, PATIENT HARM OR INJURY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356279 ↗
MalfunctionMay 17, 2024Increased Sensitivity; Increased Sensitivity
IT WAS REPORTED TO VYAIRE MEDICAL THE AVEA VENTILATOR WAS AUTO-CYCLING WHILE ON A PATIENT. CURRENTLY, NO INFORMATION REGARDING PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19347177 ↗
MalfunctionMay 6, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED TO VYAIRE MEDICAL THAT LOSS OF AIR ALARM OCCURRED WITH THE AVEA II DURING USE. NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19254939 ↗
MalfunctionApr 18, 2024High Readings; High Readings
IT WAS REPORTED TO VYAIRE MEDICAL THE FIO2 WAS READING 10% HIGHER THAN WHAT WAS SET ON THE AVEA VENTILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19139789 ↗
MalfunctionApr 10, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENT'S SCREEN IS BLANK UPON STARTUP. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19079802 ↗
MalfunctionMar 21, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE COMPRESSOR IS NOT WORKING, CAUSING LOSS OF AIR ALARM. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18951880 ↗
MalfunctionMar 21, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENT WENT INOPERABLE AFTER PERFORMING PM. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18949164 ↗
MalfunctionMar 13, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA II HAS DEVICE ERROR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895274 ↗
MalfunctionMar 11, 2024Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED TO VYAIRE MEDICAL THAT FRACTION OF INSPIRED OXYGEN SET TO 40% READING 60% ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18877920 ↗
MalfunctionMar 11, 2024Defective Device; Defective Device
IT WAS REPORTED TO VYAIRE MEDICAL THAT DEVICE ERROR OCCURRED ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874992 ↗
MalfunctionMar 8, 2024Failure to Sense; Failure to Sense
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA II ALARMED VENT INOP (VENTILATOR INOPERABLE). THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18866165 ↗
MalfunctionMar 8, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA II HAS LOW FIO2 (FRACTION OF INSPIRED OXYGEN) 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 18865900 ↗
MalfunctionMar 7, 2024Inaccurate Delivery; Inaccurate Delivery
IT WAS REPORTED TO VYAIRE MEDICAL THAT HIGH FRACTION OF INSPIRED OXYGEN OCCURRED ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18860044 ↗
MalfunctionJan 20, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR IS MAKING HISSING SOUND AND BATTERY DISCHARGE FROM THE AVEA VENTILATOR DURING PREVENTIVE MAINTENANCE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18548946 ↗
MalfunctionJan 3, 2024Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAD A VENT INOP ALARM. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18441315 ↗
MalfunctionJan 2, 2024No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT INSPIRATORY HOLD BUTTON DOES NOT WORK AND WHITE SCREEN ON THE AVEA II VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432479 ↗
MalfunctionDec 29, 2023No Display/Image; No Display/Image
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA 2 VENTILATOR INSPIRATORY HOLD BUTTON NO LONGER WORKS AND NOW A WHITE SCREEN. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18422157 ↗
MalfunctionDec 29, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA 2 VENTILATOR INSPIRATORY HOLD BUTTON NO LONGER WORKS AND NOW A WHITE SCREEN. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18422125 ↗
MalfunctionDec 29, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED TO VYAIRE MEDICAL THAT INSPIRATORY HOLD BUTTON DOES NOT WORK ON THE AVEA II VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18422009 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103211. One submission often covers many models, so check the product and lot details in each record.

Z-1888-2016 · May 17, 2016 · Terminated
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predeter
Z-1891-2016 · May 17, 2016 · Terminated
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering
Z-1894-2016 · May 17, 2016 · Terminated
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the brea
Z-1890-2016 · May 17, 2016 · Terminated
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering
Z-1899-2016 · May 17, 2016 · Terminated
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxyg
Z-1889-2016 · May 17, 2016 · Terminated
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined
Z-1893-2016 · May 17, 2016 · Terminated
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by d
Z-1892-2016 · May 17, 2016 · Terminated
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a pred
Z-1895-2016 · May 17, 2016 · Terminated
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predeterm
Z-1898-2016 · May 17, 2016 · Terminated
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of
Z-1896-2016 · May 17, 2016 · Terminated
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of ox
Z-1897-2016 · May 17, 2016 · Terminated
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined per
Z-1609-2015 · Apr 3, 2015 · Terminated
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predeterm
Z-2273-2013 · Sep 5, 2013 · Terminated
Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A cont
Z-0510-2012 · Sep 8, 2011 · Terminated
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It

Device details

UDI-DI	`10846446066074`
Brand	AVEA 2 VENTILATOR
Model	32029-001
Company	Vyaire Medical, Inc.
Product code	CBK · Ventilator, Continuous, Facility Use
Class	Class 2
FDA submission	K103211
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 30, 2024

Device type (GMDN): Neonatal/adult intensive-care ventilator

A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

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All Ventilator, Continuous, Facility Use devices →

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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