AVANOS 20-5431Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770457437), received between Nov 7, 2022 and Nov 7, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 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.

• MalfunctionNov 7, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ALL ASSOCIATED WITH THE SAME (ONE) UNIT, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. SEE MW#: 9611594-2022-00134 FOR THE FIRST EVENT. SEE MW#: 9611594-2022-00135 FOR THE SECOND EVENT. SEE MW#: 9611594-2022-00136 FOR THE THIRD EVENT. IT WAS REPORTED THAT THE NASOGASTRIC TUBE (NGT) WAS SLIDING WITH THE AMT BRIDLE PRO IN PLACE. THE NGT WAS PLACED ON (B)(6) 2022. ON (B)(6) 2022, THE RN NOTED THAT THE NGT WAS PULLED OUT TO THE THIRTY-NINE CENTIMETER MARKING WITH THE AMT BRIDLE PRO IN PLACE. THE NGT AND AMT BRIDLE PRO WERE REMOVED, AND A NEW NGT AND AMT BRIDLE PRO WERE PLACED. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749249 ↗
• MalfunctionNov 7, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ALL ASSOCIATED WITH THE SAME (ONE) UNIT, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE THIRD OF FOUR REPORTS. SEE MW#: 9611594-2022-00134 FOR THE FIRST EVENT. SEE MW#: 9611594-2022-00135 FOR THE SECOND EVENT. SEE MW#: 9611594-2022-00137 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE NASOGASTRIC TUBE (NGT) WAS SLIDING WITH THE CORGRIP IN PLACE. THE AMT BRIDLE PRO WAS PLACED ON (B)(6) 2022. ON (B)(6) 2022, THE NURSE (RN) NOTED THAT THE NGT WAS PULLED OUT TO THE FORTY-FIVE CM MARKING WITH AMT BRIDLE PRO IN PLACE. AN X-RAY WAS PERFORMED, AND AN ORDER WAS RECEIVED THAT THE NGT WAS OK TO BE USED. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748964 ↗
• MalfunctionNov 7, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 4 DIFFERENT INCIDENCES, WHICH WERE ALL ASSOCIATED WITH THE SAME (ONE) UNIT, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE SECOND OF FOUR REPORTS. SEE MW#: 9611594-2022-00134 FOR THE FIRST EVENT. SEE MW#: 9611594-2022-00136 FOR THE THIRD EVENT. SEE MW#: 9611594-2022-00137 FOR THE FOURTHEVENT. IT WAS REPORTED THAT THE NASOGASTRIC TUBE (NGT) WAS SLIDING WITH THE BRIDLE PRO IN PLACE. THE NGT WAS PLACED ON (B)(6) 2022. ON (B)(6) 2022, THE NGT WAS PULLED OUT FROM PATIENT AND REINSERTED TO THE 50 CM MARKING (BRIDLE PRO REMAINS IN PLACE). NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748888 ↗
• MalfunctionNov 7, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ALL ASSOCIATED WITH THE SAME (ONE) UNIT, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE FIRST OF FOUR REPORTS. SEE MW#: 9611594-2022-00135 FOR THE SECOND EVENT. SEE MW#: 9611594-2022-00136 FOR THE THIRD EVENT. SEE MW#: 9611594-2022-00137 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE NASOGASTRIC TUBE (NGT) WAS SLIDING WITH THE AMT BRIDLE PRO IN PLACE. THE NGT WAS PLACED ON (B)(6) 2022. ON (B)(6) 2022, IT MIGRATED FIVE CENTIMETERS (CM). THE TUBE WAS PULLED OUT FROM PATIENT, REINSERTED TO THE FIFTY CM MARKING AND BRIDLE PRO WAS PLACED. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15747578 ↗