AVANOS B70811Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00609038001043), received between Dec 31, 2022 and Dec 31, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2022Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 8030647-2022-00237 FOR THE FIRST REPORT. REFER TO 8030647-2022-00238 FOR THE SECOND REPORT. REFER TO 8030647-2022-00239 FOR THE THIRD REPORT . IT WAS REPORTED, THE MANIFOLD CRACKED ON THE BALLARD, IN THE CRITICAL CARE UNIT (CCU), AND IT CAUSED INADEQUATE AIRFLOW. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16081255 ↗
• MalfunctionDec 31, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  (B)(4) RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 8030647-2022-00237 FOR THE FIRST REPORT. REFER TO 8030647-2022-00238 FOR THE SECOND REPORT. REFER TO 8030647-2022-00240 FOR THE FOURTH REPORT. IT WAS REPORTED, THE MANIFOLD CRACKED ON THE BALLARD, IN THE CRITICAL CARE UNIT (CCU), AND CAUSED INADEQUATE AIRFLOW. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16081254 ↗
• MalfunctionDec 31, 2022Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 8030647-2022-00238 FOR THE SECOND REPORT. REFER TO 8030647-2022-00239 FOR THE THIRD REPORT. REFER TO 8030647-2022-00240 FOR THE FOURTH REPORT. THE NEONATAL INTENSIVE CARE UNIT (NICU) NURSE MANGER REPORTED, THE BALLAD WAS ON THE CHILD AND THEIR OXYGEN WAS AT 80% WHEN THEY NOTICED THE MANIFOLD WAS CRACKED, (THE MANIFOLD HAD BEEN REPLACED ON (B)(6) 2022 AND THE CATHETER WAS CHANGED ON (B)(6) 2022); THEY REPLACED IT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16081253 ↗
• MalfunctionDec 31, 2022Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 8030647-2022-00237 FOR THE FIRST REPORT, REFER TO 8030647-2022-00239 FOR THE THIRD REPORT, REFER TO 8030647-2022-00240 FOR THE FOURTH REPORT. IT WAS REPORTED, THEY REPLACED ¿IT¿ [PART OF THE VENT CIRCUIT] WITH A NEW ONE AND THE OXYGEN LEVELS WENT DOWN TO 40%. ADDITIONAL INFORMATION RECEIVED 12DEC2022 REPORTED, THE SUCTION BALLARD AND MANIFOLD WERE REPLACED, AND THE PROBLEM CORRECTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16081252 ↗