AVEA™ 17312-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752159051), received between Apr 29, 2024 and May 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (2 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA VENTILATOR HAD A LEAK WHEN ATTEMPTING TO CALIBRATE TRANSDUCERS. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393508 ↗
• MalfunctionMay 24, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED TO VYAIRE MEDICAL THAT USER INTERFACE MODULE IS FLICKERING ON THE AVEA VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION ON PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392343 ↗
• MalfunctionMay 22, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER IS EXPERIENCING A PROBLEM WITH THE UIM, IT IS DIM AND THE CLOCK BATTERY IS DEFECTIVE. PROBLEM WAS FOUND DURING THE PM PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371883 ↗
• MalfunctionApr 29, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AVEA¿S SCREEN IS WORKING INTERMITTENTLY AND WILL GO FUZZY. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203362 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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