VyaireRecalls & reported problems across all models
Jaeger Medical GmbH · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Vyaire model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 17 models of Vyaire by Jaeger Medical GmbH in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jun 6, 2019 and May 28, 2025 — classified as 4 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (10 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Vyaire recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 8, 2024Open, Classified
Potential of the nozzle separating during patient use.
Z-1730-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Vyaire problems
Device problems
- Battery Problem10
- Mechanical Problem7
- Detachment of Device or Device Component4
- Adverse Event Without Identified Device or Use Problem3
- Failure to Calibrate3
- Component Misassembled2
- Sharp Edges2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Abrasion3
- Insufficient Information2
- No Patient Involvement2
- Aspiration/Inhalation1
- Bruise/Contusion1
- Convulsion/Seizure1
- Cough1
Vyaire models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vyaire V-707327Calculator, Pulmonary Function Data1 recall0 reports
- Vyaire V-178500-13Calculator, Pulmonary Function Data6 reports
- Vyaire V-892380Filter, Bacterial, Breathing-Circuit5 reports
- Vyaire V-178501Oximeter5 reports
- Vyaire V-178500Calculator, Pulmonary Function Data4 reports
- Vyaire V-178603Calculator, Pulmonary Function Data3 reports
- Vyaire V-171466-13Calculator, Predicted Values, Pulmonary Function3 reports
- Vyaire V-178601Calculator, Pulmonary Function Data2 reports
- Vyaire V-707254Calculator, Predicted Values, Pulmonary Function2 reports
- Vyaire V-707960Calculator, Pulmonary Function Data2 reports
- Vyaire V-178602Calculator, Pulmonary Function Data1 report
- Vyaire V-178600-13Calculator, Pulmonary Function Data1 report
- Vyaire V-378540Calculator, Pulmonary Function Data1 report
- Vyaire V-892381Filter, Bacterial, Breathing-Circuit1 report
- Vyaire V-892384Filter, Bacterial, Breathing-Circuit1 report
- Vyaire 36-ML3535 MK8-STKSpirometer, Diagnostic1 report
- Vyaire 36-ML3500 MK8-STKSpirometer, Diagnostic1 report
Recent Vyaire adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗MalfunctionApr 3, 2025Battery Problem; Battery Problem
THE CUSTOMER COMPLAINED THAT THE BATTERY OF THE VYNTUS WALK TABLET IS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761616 ↗MalfunctionApr 3, 2025Battery Problem; Battery Problem
THE CUSTOMER COMPLAINED THAT THE BATTERY OF THE VYNTUS WALK TABLET IS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761606 ↗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 ↗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 ↗MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 30-OCT-2024 VYAIRE WAS INFORMED BY A CUSTOMER THAT THE USS MODULE BECAME DISLODGED FROM THE FPV BLOCK WHEN PATIENT ACCIDENTLY PULLED IT OUT DURING SPIROMETRY TEST. THE MODULE DID NOT HIT THE FLOOR BUT THE USS CABLE DISCONNECT WHICH CAUSED DAMAGE TO THE CABLE. NO PATIENT HARM OCCURRED AND PATIENT DID NOT REQUIRE ANY MEDICAL ATTENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20796880 ↗MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 10/24/2024 IT WAS REPORTED TO VYAIRE THAT WHEN THE PATIENT PULLED ON THE USS SENSOR TO READJUST THE POSITIONING OF THE ARM THE USS SENSOR FELL OUT OF HOUSING. THIS RESULTED IN THE USS SENSOR HITTING THE PATIENT'S FACE AND CAUSING A CUT ON THE LIP. IT WAS REQUIRED TO APPLY A PLASTER/TISSUE TO THE INJURED LIP TO STOP THE BLEEDING. THIS INCIDENT OCCURRED TWICE IN THE SAME HOSPITAL, BUT WITH A DIFFERENT PATIENT ON A DIFFERENT DEVICE AND WITH ANOTHER HEALTHCARE PROFESSIONAL. THE OTHER INCIDENT WILL BE REPORTED IN A SECOND REPORT WITH OUR REFERENCE NUMBER (B)(4).
Patient problems: Abrasion
MAUDE report 20755730 ↗MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024 IT WAS REPORTED TO VYAIRE THAT WHEN THE PATIENT PULLED ON THE USS SENSOR TO READJUST THE POSITIONING OF THE ARM THE USS SENSOR FELL OUT OF HOUSING. THIS RESULTED IN THE USS SENSOR HITTING THE PATIENT'S FACE AND CAUSING A CUT ON THE LIP. IT WAS REQUIRED TO APPLY A PLASTER/TISSUE TO THE INJURED LIP TO STOP THE BLEEDING. THIS INCIDENT OCCURRED TWICE IN THE SAME HOSPITAL, BUT WITH A DIFFERENT PATIENT ON A DIFFERENT DEVICE AND WITH ANOTHER HEALTHCARE PROFESSIONAL. THE OTHER INCIDENT WILL BE REPORTED IN A SECOND REPORT WITH OUR REFERENCE NUMBER COM (B)(4).
Patient problems: Abrasion
MAUDE report 20755703 ↗MalfunctionNov 21, 2024Detachment of Device or Device Component; Environmental Particulates; Detachment of Device or Device Component; Environmental Particulates
ON 22-OCT-2024 VYAIRE WAS INFORMED BY A CUSTOMER, THAT THE USS MODULE WAS DROPPED WHILE CONDUCTING THE TEST ON PATIENT AND THE USS CABLE DISLODGE FROM THE SENSOR LEAVE ONLY THE CABLE COVER ON IT. THE CUSTOMER RECONNECTED THE CABLE TO THE USS SENSOR WITHOUT TURNING OFF THE VYNTUS BODY. DUE TO THE MISSING CABLE COVER THIS RESULTED IN SMOKE COMING OUT OF THE FPV MODULE. THERE WAS NO PATIENT HARM REPORTED, FURTHER INFORMATION IS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20746540 ↗MalfunctionOct 31, 2024Battery Problem; Battery Problem
THE CUSTOMER COMPLAINED THAT THE BATTERY OF THE DELL LAPTOP IS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577310 ↗MalfunctionSep 18, 2024Battery Problem; Battery Problem
THE CUSTOMER REPORTED THAT THE KEYBOARD OF THE VYNTUS SPIRO LAPTOP FROM DELL IS PUSHING UP BECAUSE OF A SWOLLEN BATTERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20243853 ↗MalfunctionSep 18, 2024Battery Problem; Battery Problem
THE CUSTOMER REPORTED THAT THE KEYBOARD OF THE VYNTUS ONE LAPTOP FROM DELL IS PUFFED OUT, WHICH POSSIBLY COULD BE THE RESULT OF A SWOLLEN BATTERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20243843 ↗MalfunctionSep 17, 2024Battery Problem; Battery Problem
THE CUSTOMER REPORTED THAT THE BATTERY OF THE VYNTUS SPIRO LAPTOP WAS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236685 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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