AVANOS 94827Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770948270), received between Dec 28, 2019 and Jan 9, 2020 — classified as 5 injuries, 1 malfunction.

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.

• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE ENTERAL FEEDING TUBE BALLOON BEGAN LEAKING AFTER 2-DAYS OF BEING IN PLACE, CAUSING SKIN BREAKDOWN AT THE STOMA SITE. THE SKIN BREAKDOWN WAS DUE TO GASTRIC SECRETIONS. THE PATIENT HAD TO BE PLACED ON ORAL AND TOPICAL ANTIBIOTICS, BACTROBAN OINTMENT. AT THE TIME OF THIS REPORT THE PATIENT'S SKIN HAD HEALED.

  Patient problems: Skin Irritation

  MAUDE report 9568490 ↗
• InjuryDec 30, 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 9611594-2019-00259 FOR THE FIRST EVENT. REFER TO 9611594-2019-00260 FOR THE SECOND EVENT. REFER TO 9611594-2019-00262 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00263 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 9532171 ↗
• 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 9611594-2019-00259 FOR THE FIRST EVENT. REFER TO 9611594-2019-00261 FOR THE THIRD EVENT. REFER TO 9611594-2019-00262 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00263 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 9528445 ↗
• 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 9611594-2019-00259 FOR THE FIRST EVENT. REFER TO 9611594-2019-00260 FOR THE SECOND EVENT. REFER TO 9611594-2019-00261 FOR THE THIRD EVENT. REFER TO 9611594-2019-00262 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 9528444 ↗
• 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 9611594-2019-00260 FOR THE SECOND EVENT. REFER TO 9611594-2019-00261 FOR THE THIRD EVENT. REFER TO 9611594-2019-00262 FOR THE FOURTH EVENT. REFER TO 9611594-2019-00263 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 9528443 ↗
• 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 9611594-2019-00259 FOR THE FIRST EVENT. REFER TO 9611594-2019-00260 FOR THE SECOND EVENT. REFER TO 9611594-2019-00261 FOR THE THIRD EVENT. REFER TO 9611594-2019-00263 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 9528442 ↗