Vyaire V-178600-13Recalls & reported problems
Jaeger Medical GmbH · Vyntus ONE · Class 2
All models of Vyaire (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250892904733), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem1
Patient problems
- Dyspnea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
THIS IS A SUPPLEMENTAL REPORT TO THE ALREADY EXISTING INITIAL REPORT WITH MFR REPORT#: 9615102-2022-00130. DUE TO A SOFTWARE CHANGE IT IS NOT POSSIBLE TO REFER TO THE OLD COMPLAINT, SO THIS IS INCORRECTLY MARKED AS AN INITIAL REPORT. IT WAS REPORTED TO VYAIRE MEDICAL THAT THE PATIENT WAS HAVING DIFFICULTY TAKING A BREATH IN DURING DLCO, IT WAS ALMOST LIKE A STUTTERING OR THERE WAS A "POP OFF" HAPPENING. MODULE WAS REPLACED BACK IN FEBRUARY. THE USER STATED THAT THE PATIENT SEEM TO HAVE A MORE DIFFICULT TIME BREATHING AND TAKING THE BREATH IN ON THIS UNIT VS THE BODY BOX.
Patient problems: Dyspnea
MAUDE report 21620678 ↗
Other Calculator, Pulmonary Function Data devices
- Vyaire V-707327Jaeger Medical GmbH · Calculator, Pulmonary Function Data1 recall0 reports
- Vyaire V-178500-13Jaeger Medical GmbH · Calculator, Pulmonary Function Data6 reports
- Vyaire V-178500Jaeger Medical GmbH · Calculator, Pulmonary Function Data4 reports
- Vyaire V-178603Jaeger Medical GmbH · Calculator, Pulmonary Function Data3 reports
- Vyaire V-178601Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Jaeger V-175423Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Jaeger 172520Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
- Vyaire V-707960Jaeger Medical GmbH · Calculator, Pulmonary Function Data2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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