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Vyaire 36-ML3535 MK8-STKRecalls & reported problems

Jaeger Medical GmbH · MicroLoop · 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 54250892905469), received between Oct 3, 2019 and Oct 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (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.

Most reported problems

Device problems

  • Smoking1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 3, 2019Smoking; Smoking

    THE CUSTOMER REPORTED BURNT ELECTRONIC BOARD FROM THE MICROLAB-LOOP DEVICE. THE CUSTOMER REPORTED THE EQUIPMENT BEGAN TO SMELL LIKE SMOKE AND WAS IDENTIFIED BY THE TECHNICIAN THROUGH THE BURNING SMELL. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Patient problems: No Patient Involvement

    MAUDE report 9151983 ↗

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Sources and updates

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