Vyaire V-892381Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34250892903034), received between Jun 6, 2019 and Jun 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sharp Edges” (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

Recent adverse event reports

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

• MalfunctionJun 6, 2019Sharp Edges; Sharp Edges

  CUSTOMER REPORTED THAT A SHARP SHARD WAS EXTRACTED BY THE LABORATORY STAFF FROM THE MICROGARD II FILTER BEFORE TEST, IN RESPONSE TO A RATTLING NOISE IN THE FILTER. THEY KEPT THE SHARP SHARD AND THERE WAS NO APPARENT BREAKAGE OF THE FILTER . THEY THREW AWAY THE FILTER, BUT RETAINED THE SHARD AND THE PLASTIC PRODUCT BAG. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8676573 ↗