Revel 19260-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190752157071), received between Apr 18, 2024 and Jun 24, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE VENTILATOR WAS RETURNED AND EVALUATED IN THE FA LAB. THE REPORTED COMPLAINT WAS VERIFIED AND DUPLICATED. THIS IS ISOLATED TO INCORRECT MAINTENANCE AND DEVICE MISUSE WITH THE 3 SCREWS ON THE O2 INLET PORT WHICH WERE NOT TORQUED TO SPECIFICATIONS AND THE DAMAGED O-RING CAUSES THE LEAK FROM THE O2 BLENDER MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594072 ↗
• InjuryJun 21, 2024Intermittent Infusion; Intermittent Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR HAD A DAMAGED POWER PIGTAIL AND WAS GIVING THE PATIENT INTERMITTENT BIPAP BREATHS "VENT WAS ON THE PATIENT. IT SEEMED TO BE WORKING FINE, THEN JUST STOPPED DELIVERING A BREATH, REPEATEDLY WHILE WE WERE TROUBLESHOOTING. THE PATIENT WAS SIGNALING THAT SHE COULDN'T GET A BREATH, WE TRIED TROUBLESHOOTING IT AND ON THE THIRD TIME WE REMOVED IT AND PUT HER ON FLOW DRIVEN CPAP." NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583667 ↗
• InjuryMay 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL, THE BLOWER DEMAND EXCEEDED ALARM OCCURRED WHILE TRANSPORTING A PATIENT. PATIENT INVOLVED, BUT NO HARM OR INJURY TO PATIENT. TRACH PATIENT WAS PUT ON ANOTHER VENTILATOR WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370745 ↗
• InjuryMay 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE UNIT RUNNING ON A PATIENT DURING A TRANSPORT. THIS UNIT WAS RUNNING ON THE PATIENT ON VOLUME AC, VT 450, RATE 18. IT WAS NOTICED THE RESPIRATORY RATE ON THEIR EXTERNAL ETCO2 MONITOR WAS READING 12-14 CONSISTENTLY. THEY ARE AWARE THIS IS AN EXTERNAL MONITOR, NOT THE VENT. THE VENT WAS READING 18 AS WELL. THEY TOOK THE UNIT ASIDE AFTER THE TRANSPORT AND HAD THE RATE STILL SET TO 18 AND TIMED THE BREATHS WITH A WATCH AND GOT 12 BREATHS PER MINUTE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282392 ↗
• MalfunctionApr 18, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR IS NOT GENERATING VOLUME. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133535 ↗

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-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-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-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-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-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-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-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-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-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-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-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