Vyaire V-892380Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14250892903115), received between Oct 25, 2023 and Apr 17, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (2 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, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Sharp Edges; Sharp Edges

  THE CUSTOMER REPORTED THAT THE MICROGARD FILTER HAS SHARP EDGES. THERE WAS NO PATIENT INVOLVEMENT REPORTED SINCE THE EVENT OCCURRED DURING AN INCOMING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856584 ↗
• InjuryJan 15, 2025Contamination; Contamination

  THE CUSTOMER REPORTED TO VYAIRE ON (B)(6)2024 THAT A LUNG INJURY OCCURRED WHILE INHALING DURING A SPIROMETRY MEASUREMENT. DURING A FORCED SPIROMETRY MEASUREMENT FOR A NOCION CHRONIC COUGH STUDY USING THE MICROGARD II FILTER, THE TEST PATIENT FELT LIKE SHE HAD INHALED SOMETHING FROM THE DEVICE. AS A RESULT, THE PATIENT HAD TO COUGH AND THE VOICE BECAME UNUSUAL AND IRRITATED. A DOCTOR EXAMINED HER THROAT AND LISTENED TO HER LUNGS AND SUGGESTED THAT SHE GO TO THE ER FOR A CT SCAN BECAUSE HE BELIEVED THAT SHE HAD A TRACHEAL TEAR. A CT SCAN SHOWED THAT SHE DID HAVE A TRACHEAL TEAR. A SURGEON WAS CONSULTED AND AFTER TWO DAYS OF OBSERVATION, IT WAS DETERMINED THAT SHE WOULD NOT NEED SURGERY. AFTER TWO DAYS THE TEST PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SITE COORDINATOR CONDUCTING THE TEST INSPECTED THE MACHINE AND ALL DEVICES THAT WERE ATTACHED BUT DID NOT OBSERVE ANYTHING UNUSUAL.

  Patient problems: Aspiration/Inhalation

  MAUDE report 21158669 ↗
• MalfunctionJun 24, 2024Failure to Calibrate; Component Misassembled; Failure to Calibrate; Component Misassembled

  THE CUSTOMER COMPLAINED THAT THE FILTER-LINING OF THE MICROGARD FILTER IS MISPLACED. THIS WAS NOTICED DURING AN INCOMING INSPECTION. THERE WAS NO INDICATION THAT DEFECTIVE FILTERS WERE USED FOR PATIENT MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592379 ↗
• MalfunctionJun 19, 2024Failure to Calibrate; Component Misassembled; Failure to Calibrate; Component Misassembled

  THE CUSTOMER COMPLAINED THAT THE FILTER-LINING OF THE MICROGARD FILTER IS MISPLACED. THIS WAS NOTICED DURING AN INCOMING INSPECTION. THERE WAS NO INDICATION THAT DEFECTIVE FILTERS WERE USED FOR PATIENT MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565041 ↗
• MalfunctionOct 25, 2023Component Missing; Component Missing

  IT WAS REPORTED TO VYAIRE THAT THE CUSTOMER (B)(6) GMBH RECEIVED A DELIVERY FROM VYAIRE WITH TWO MICROGARD FILTERS THAT WERE INCOMPLETE. IT WAS STATED THAT THE FILTER INLAY WAS MISSING FOR ONE FILTER, AND THE OTHER WAS MISSING 1/2 OF THE FILTER HOUSING. THE FILTERS WERE IDENTIFIED AND RETURNED TO VYAIRE FOR ANALYSIS. THE FILTERS WERE RETURNED INSIDE THEIR ORIGINAL & SEALED PACKAGING; THERE IS NO INDICATION THAT INCOMPLETE FILTERS WERE USED FOR PATIENT MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008557 ↗