Vyaire V-178500-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04250892904689), received between Jul 9, 2021 and Apr 24, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT DURING INSTALLATION OF THE VYNTUS BODYBOX DOOR THE DOOR FELL ON THE SERVICE TECHNICIAN. THERE WAS NO PHYSICAL HARM TO THE SERVICE TECHNICIAN BESIDES FRAGMENTS OF GLASS ENTERING HIS HAIR AND FOOTWEAR. IT WAS CONFIRMED THAT THE TECHNICIAN WAS NOT WEARING THE NECESSARY SAFETY CLOTHING (E.G. SAFETY GLOVES, SAFETY GOGGLES) FOR THE INSTALLATION OF A VYNTUS BODYBOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897513 ↗
• MalfunctionJul 3, 2024Unable to Obtain Readings; Unable to Obtain Readings

  VYAIRE WAS INFORMED ON THE 20-MAY-2024 BY THE FDA THAT THE CUSTOMER REPORTED THIS INCIDENT UNDER THE REFERENCE NUMBER (B)(4). THE CUSTOMER REPORTED THE FOLLOWING: "SOFTWARE MALFUNCTIONED ON OUR VYAIRE VYNTUS BODY BOX IN LAB AND COULD NOT GET SPIROMETRY TESTING SCREEN TO PULL UP. TEST IS STRICTLY TIMED, SO THREW OFF TESTING ACCURACY AND LED TO MEDICATION NEEDING TO BE ADMINISTERED AGAIN ONCE GLITCH WAS FIXED BEFORE WE COULD CONTINUE. SOFTWARE UPGRADE NEEDED AS SOON AS POSSIBLE. DIFFERENT PROBLEMS CONTINUE TO PRESENT THEMSELVES ON DIFFERENT PARTS OF TESTING ON A MORE AND MORE FREQUENT BASIS."

  Patient problems: Insufficient Information

  MAUDE report 19663740 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO VYAIRE THAT A FEMALE PATIENT SUFFERED A SEIZURE WHILE SITTING INSIDE THE VYNTUS BODY AND RESULTED IN HITTING HER HEAD ON THE GLASS WALL. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM BECAUSE SHE SUFFERED A SUBDURAL HEMATOMA. THE INCIDENT OCCURRED IN BETWEEN MEASUREMENTS. THE DEVICE DID NOT MALFUNCTION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

  Patient problems: Convulsion/Seizure

  MAUDE report 18158351 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO VYAIRE THAT AFTER A PLETHYSMOGRAPHY MEASUREMENT, A MALE PATIENT BECAME DIZZY AND FELL OUT OF THE BOX. IT RESULTED IN A MINOR INJURY OF LACERATION ON THE FOREHEAD. THE PATIENT WAS PRECAUTIONARY TAKEN TO THE EMERGENCY DEPARTMENT IN THE HOSPITAL THE INCIDENT OCCURRED TO TREAT HIS LACERATION ON THE FOREHEAD.

  Patient problems: Laceration(s)

  MAUDE report 18090437 ↗
• MalfunctionFeb 23, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE BODY BOX ARRIVED ONSITE, WHEN THE WARM DOOR WAS EXPOSED TO THE COLD AIR. THE DOOR SHATTERED. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584970 ↗
• MalfunctionJul 9, 2021Mechanical Problem; Mechanical Problem

  THE SERVICE TECHNICIAN REPORTED THAT THE DOOR OF THE VYNTUS BODY EXPLODED ON HIS HANDS DURING INSTALLATION. THE SERVICE TECHNICIAN DID NOT SUSTAIN ANY INJURIES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146945 ↗