AIRCAST 30B-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912306539), received between Mar 2, 2020 and Jul 27, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fire” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2020Fire; Fire

  IT WAS REPORTED THAT THE "VENAFLOW ELITE UNIT CAUGHT FIRE IN THE OPERATING ROOM. NO ONE WAS INJURED AND THE FIRE DEPARTMENT WAS CALLED TO THE SCENE. THE MACHINE WAS CLEARED TO GO BACK INTO THE BUILDING BY THE FIRE MARSHALL AFTER THE SCENE WAS CLEARED." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10326530 ↗
• MalfunctionMar 2, 2020Fire; Fire

  IT WAS REPORTED THAT THE "VENAFLOW UNIT IN OR (OPERATING ROOM) BEGAN SMOKING AND STARTED ON FIRE. THE UNIT WAS PLUGGED IN AT THE TIME, BUT NOT IN USE ON A PATIENT."

  Patient problems: No Patient Involvement

  MAUDE report 9774031 ↗