AVEA 50000-40033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846446015966), received between May 19, 2020 and May 19, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE AVEA VENTILATOR'S BLENDER IS GIVING WRONG DATA WHICH IS OUT OF SPECIFICATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10070640 ↗

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-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-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-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-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-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-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-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-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-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-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-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