AVANOS 20-9366AIV2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770457864), received between Mar 12, 2024 and Sep 23, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (3 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.

• MalfunctionSep 23, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872979 ↗
• InjuryMar 12, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2024-00037 FOR THE FIRST EVENT. REFER TO 9611594-2024-00038 FOR THE SECOND EVENT. DURING AN ATTEMPT TO PLACE AN NGT (NASOGASTRIC TUBE) IT IS BELIEVED THAT THE TUBE ENTERED THE LUNG(S) AND CAUSED A PERFORATION RESULTING IN PNEUMOTHORAX AND REQUIRED ASSOCIATED RESUSCITATION. THE PATIENT INVOLVED ULTIMATELY RECOVERED.

  Patient problems: Pneumothorax

  MAUDE report 18888678 ↗
• InjuryMar 12, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2024-00038 FOR THE SECOND EVENT. REFER TO 9611594-2024-00039 FOR THE THIRD EVENT. DURING AN ATTEMPT TO PLACE AN NGT (NASOGASTRIC TUBE) IT IS BELIEVED THAT THE TUBE ENTERED THE LUNG(S) AND CAUSED A PERFORATION RESULTING IN PNEUMOTHORAX AND REQUIRED ASSOCIATED RESUSCITATION. THE PATIENT INVOLVED ULTIMATELY RECOVERED. ADDITIONAL INFORMATION RECEIVED 28-FEB-2024 STATES THE EVENT RESULTED IN A RIGHT LUNG PNEUMOTHORAX AND THE PATIENT WAS TREATED WITH A NEEDLE DECOMPRESSION.

  Patient problems: Pneumothorax

  MAUDE report 18888675 ↗
• InjuryMar 12, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2024-00037 FOR THE FIRST EVENT. REFER TO 9611594-2024-00039 FOR THE THIRD EVENT. DURING AN ATTEMPT TO PLACE AN NGT (NASOGASTRIC TUBE) IT IS BELIEVED THAT THE TUBE ENTERED THE LUNG(S) AND CAUSED A PERFORATION RESULTING IN PNEUMOTHORAX AND REQUIRED ASSOCIATED RESUSCITATION. THE PATIENT INVOLVED ULTIMATELY RECOVERED. ADDITIONAL INFORMATION RECEIVED 28-FEB-2024 STATES THE EVENT RESULTED IN A LEFT LUNG PNEUMOTHORAX AND THE PATIENT WAS TREATED WITH A NEEDLE DECOMPRESSION.

  Patient problems: Pneumothorax

  MAUDE report 18888673 ↗