Vyaire V-178601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250892904696), received between Mar 25, 2024 and May 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE PATIENT WAS SEATED FOR A LUNG FUNCTION TEST, THE CLINICIAN LOWERED THE ARM HOLDING THE ULTRASONIC FLOW SENSOR INTO POSITION. DURING THIS PROCESS, THE SENSOR HEAD BECAME DISLODGED FROM THE ARM AND STRUCK THE PATIENT ON THE FOREHEAD. THE PATIENT WAS PLACED UNDER OBSERVATION FOR 24 HOURS AND, ASIDE FROM EXPERIENCING MILD DERMATOLOGIC IRRITATION AND A TRANSIENT HEADACHE THE FOLLOWING DAY, SUSTAINED NO HARM. THERE WERE NO BRUISING OR CUTS OBSERVED THE FOLLOWING DAY.

  Patient problems: Headache

  MAUDE report 22094210 ↗
• MalfunctionMar 25, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER COMPLAINED THAT THE USS MODULE DETACHED FROM THE ARM AND AS A RESULT FELL ONTO THE PATIENT¿S FACE, WHICH WAS INJURED. THE PATIENT'S LIP WAS BRUISED AND CUT. FIRST AID WAS ADMINISTERED BY THE HEALTH CARE PROVIDER. THEY USED A COLD TISSUE AND COMPRESSION. NO FURTHER FIRST AID WAS REPORTED.

  Patient problems: Abrasion; Bruise/Contusion

  MAUDE report 18967065 ↗