AVANOS 94828Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770948287), received between Dec 28, 2019 and May 20, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Pressure Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE PARENT OF THE PATIENT THAT HER SON¿S TUBE WAS PLACED IN LATE DECEMBER- EARLY JANUARY AND IS DEFECTIVE. THE BALLOON IS ASYMMETRICAL, AND THE PATIENT HAD BLEEDING FROM ABDOMINAL REGION REQUIRING A VISIT TO EMERGENCY ROOM. 14 DAYS OF ANTIBIOTICS WERE PRESCRIBED. A NEW TUBE WAS PLACED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19353999 ↗
• InjuryDec 28, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 9611594-2019-00264 FOR THE FIRST EVENT. REFER TO 9611594-2019-00265 FOR THE SECOND EVENT. REFER TO 9611594-2019-00266 FOR THE THIRD EVENT. REFER TO 9611594-2019-00268 FOR THE FIFTH EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED SKIN BREAKDOWN AND PRESSURE UNDER THE NEWLY PLACED MIC-KEY GASTROSTOMY TUBE. THE SURGEONS PLACING THE DEVICE ARE DISAGREEING WITH THE WOUND OSTOMY TEAM THAT THESE ARE PRESSURE RELATED INJURIES. HOWEVER, THE WOUND OSTOMY CARE NURSE (WOCN) TEAM IS STAGING IT AS A PRESSURE INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 9528451 ↗
• InjuryDec 28, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 9611594-2019-00264 FOR THE FIRST EVENT. REFER TO 9611594-2019-00265 FOR THE SECOND EVENT. REFER TO 9611594-2019-00267 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00268 FOR THE FIFTH EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED SKIN BREAKDOWN AND PRESSURE UNDER THE NEWLY PLACED MIC-KEY GASTROSTOMY TUBE. THE SURGEONS PLACING THE DEVICE ARE DISAGREEING WITH THE WOUND OSTOMY TEAM THAT THESE ARE PRESSURE RELATED INJURIES. HOWEVER, THE WOUND OSTOMY CARE NURSE (WOCN) TEAM IS STAGING IT AS A PRESSURE INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 9528448 ↗
• InjuryDec 28, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 9611594-2019-00264 FOR THE FIRST EVENT. REFER TO 9611594-2019-00265 FOR THE SECOND EVENT. REFER TO 9611594-2019-00266 FOR THE THIRD EVENT. REFER TO 9611594-2019-00267 FOR THE FOURTH EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED SKIN BREAKDOWN AND PRESSURE UNDER THE NEWLY PLACED MIC-KEY GASTROSTOMY TUBE. THE SURGEONS PLACING THE DEVICE ARE DISAGREEING WITH THE WOUND OSTOMY TEAM THAT THESE ARE PRESSURE RELATED INJURIES. HOWEVER, THE WOUND OSTOMY CARE NURSE (WOCN) TEAM IS STAGING IT AS A PRESSURE INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 9528447 ↗
• InjuryDec 28, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 9611594-2019-00264 FOR THE FIRST EVENT. REFER TO 9611594-2019-00266 FOR THE THIRD EVENT. REFER TO 9611594-2019-00267 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00268 FOR THE FIFTH EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED SKIN BREAKDOWN AND PRESSURE UNDER THE NEWLY PLACED MIC-KEY GASTROSTOMY TUBE. THE SURGEONS PLACING THE DEVICE ARE DISAGREEING WITH THE WOUND OSTOMY TEAM THAT THESE ARE PRESSURE RELATED INJURIES. HOWEVER, THE WOUND OSTOMY CARE NURSE (WOCN) TEAM IS STAGING IT AS A PRESSURE INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 9528446 ↗
• InjuryDec 28, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 9611594-2019-00265 FOR THE SECOND EVENT. REFER TO 9611594-2019-00266 FOR THE THIRD EVENT. REFER TO 9611594-2019-00267 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00268 FOR THE FIFTH EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED SKIN BREAKDOWN AND PRESSURE UNDER THE NEWLY PLACED MIC-KEY GASTROSTOMY TUBE. THE SURGEONS PLACING THE DEVICE ARE DISAGREEING WITH THE WOUND OSTOMY TEAM THAT THESE ARE PRESSURE RELATED INJURIES. HOWEVER, THE WOUND OSTOMY CARE NURSE (WOCN) TEAM IS STAGING IT AS A PRESSURE INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 9528441 ↗