AVANOS B30511Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038000411), received between Jan 3, 2018 and Jun 8, 2020 — classified as 2 malfunctions.

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

• MalfunctionJun 8, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DEVICE "WAS STARTED TO BE USED AT 6:30. [THE PATIENT'S] RESPIRATORY CONDITION GOT WORSE AT 23:00. IT WAS FOUND THAT THE DISTAL TIP CAME OFF AND THE PATIENT ACCIDENTALLY SWALLOWED IT. THE TIP WAS ALREADY REMOVED FROM THE PATIENT WITH ADDITIONAL SUCTIONING PROCEDURE. NOW THE PATIENT¿S CONDITION IS STABLE. THE DISTAL TIP SEEMED IT WAS NOT UNSTABLE BEFORE USE. THERE WAS A POSSIBILITY THAT THE PATIENT BIT THE TIP DURING THE PROCEDURE. IT WAS SUSPECTED THAT THE TIP WAS STUCK AT AROUND THE ESOPHAGUS."

  Patient problems: Foreign Body In Patient

  MAUDE report 10129138 ↗
• MalfunctionJan 3, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PROBE TIP DETACHED IN THE PATIENT'S MOUTH, AND THE PATIENT SWALLOWED IT. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 7161714 ↗