AVANOS 44154Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770441542), received between Apr 12, 2022 and Apr 12, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 12, 2022Material Rupture; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2022-00041 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE BALLOON FAILURE REQUIRED MEDICAL INTERVENTION, THE PATIENT WAS RETURNED TO THE OPERATING ROOM BECAUSE OF THE MALFUNCTION. NO INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 15MAR2022, THE PHYSICIAN REPORTED THAT, AN ADVERSE EVENT CERTAINLY HAPPENED, AS A RESULT OF THE MALFUNCTIONING TUBE. IT WAS REPORTED THAT THE PATIENT¿S TUBE FELL OUT WITHIN 24 HOURS [OF PLACEMENT] THE TRACT WAS NOT FORMED, AND THE PATIENT HAD TO HAVE A SECOND PROCEDURE TO REPLACE THE TUBE. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14089908 ↗
• MalfunctionApr 12, 2022Material Rupture; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2022-00040 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE BALLOON FAILURE REQUIRED MEDICAL INTERVENTION, THE PATIENT WAS RETURNED TO THE INTERVENTIONAL RADIOLOGY TO HAVE THE TUBE REPLACED. NO INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14085103 ↗