AVANOS 42699Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770426990), received between Nov 24, 2020 and Apr 14, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• MalfunctionApr 14, 2026Malposition of Device

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) THE FOLLOWING: MICKEY'S G-TUBE BALLOON RUPTURED, CAUSING THE FEEDING TUBE TO FALL OUT OF THE PATIENT, MARKING THE PRODUCT UNUSABLE, THUS UNABLE TO FEED INFANT. S- [SITUATION]: 6-DAY POST OP GT [GASTRIC TUBE] DISLODGED. GT BALLOON FOUND TO BE RUPTURED. B- [BACKGROUND]: EX PREMIE, 6 DAYS POST OP TRACH/GT [TRACHEOSTOMY/GASTRIC TUBE]. A- [ASSESSMENT]: SUTURES REMOVED DURING A PREVIOUS SHIFT, OK FROM PA [PHYSICIAN ASSISTANT] TO REMOVE BOLSTER DRESSING. BOLDSTER DRESSING REMOVED. GT NOT LEAKING AT SITE, NO INDICATION TO CHECK WATER IN BALLOON. SURGERY CALLED TO BEDSIDE, NEW GT PLACED, CONTRAST STUDY COMPLETED AND FEEDINGS RESUMED. PATIENT HAD A 12 FR MICKEY G-TUBE BUTTON INFLATED WITH 4 ML OF STERILE WATER WITH NO LEAK NOTED AT THE TIME OF INSERTION. ON [REDACTED], THE G-TUBE BUTTON WAS FOUND DISLODGED WITH A VISIBLE HOLE IN THE BALLOON AND LEAKING WATER. THE G-TUBE HAD BEEN SECURED APPROPRIATELY PRIOR TO THE EVENT. CONFIRMED WITH THE PRODUCT IFU [INSTRUCTIONS FOR USE], 12 FR MICKEY HAS A SUGGESTED FILL VOLUME OF 3-5 ML. THUS, BALLOON WAS FILLED WITH APPROPRIATE AMOUNT OF STERILE WATER. THERE WAS NO REPORTED INJ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876452 ↗
• InjuryFeb 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT, PER ADDITIONAL INFORMATION RECEIVED, INVOLVED THREE SEPARATE DEVICES, ALL INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2021-00180 FOR THE FIRST REPORT. REFER TO 9611594-2022-00015 FOR THE SECOND REPORT. IT WAS REPORTED THAT A PATIENT HAS BEEN PULLING OUT HIS FEEDING TUBE SEVERAL TIMES A WEEK, WHICH CAUSED IT TO BREAK. THE REPORTING NURSE BELIEVES THE CHILD IS PULLING OUT THE TUBE DUE TO PAIN AND POSSIBLE GRANULOMA IN THE STOMA SITE. THE PATIENT HAS BEEN TREATED WITH PRESCRIPTION DROPS IN THE STOMA. THE PATIENT HAD BEEN PREVIOUSLY GIVEN A 14FR BUTTON BUT WAS CHANGED TO 12FR DUE TO THE DOCTOR HAVING NONE IN STOCK. PER ADDITIONAL INFORMATION RECEIVED, THE REPORTER CLARIFIED THAT THERE HAVE BEEN DISCUSSIONS REGARDING IF THE REPORTED ISSUE IS BEING CAUSED BY A GRANULOMA IN THE STOMA, BUT NO TREATMENT FOR GRANULOMA (PRESCRIPTION DROPS) HAS BEEN PROVIDED YET. CULTURES TAKEN FROM THE STOMA WERE POSITIVE FOR CANDIDA AND THEREFORE A DIFLUCAN MIXTURE WAS PRESCRIBED. THE DEVICE WAS CHANGED OUT "FROM A SLIGHTLY TOO SHORT 12 FR TO 14 FR IN THE RIGHT LENGTH" AND THERE HAVE BEEN NO FURTHER ISSUES WITH THE TUBE B

  Patient problems: Fungal Infection; Granuloma; Pain

  MAUDE report 13545924 ↗
• InjuryFeb 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT, PER ADDITIONAL INFORMATION RECEIVED, INVOLVED THREE SEPARATE DEVICES, ALL INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2021-00180 FOR THE FIRST REPORT. REFER TO 9611594-2022-00016 FOR THE THIRD REPORT. IT WAS REPORTED THAT A PATIENT HAS BEEN PULLING OUT HIS FEEDING TUBE SEVERAL TIMES A WEEK, WHICH CAUSED IT TO BREAK. THE REPORTING NURSE BELIEVES THE CHILD IS PULLING OUT THE TUBE DUE TO PAIN AND POSSIBLE GRANULOMA IN THE STOMA SITE. THE PATIENT HAS BEEN TREATED WITH PRESCRIPTION DROPS IN THE STOMA. THE PATIENT HAD BEEN PREVIOUSLY GIVEN A 14FR BUTTON BUT WAS CHANGED TO 12FR DUE TO THE DOCTOR HAVING NONE IN STOCK. PER ADDITIONAL INFORMATION RECEIVED, THE REPORTER CLARIFIED THAT THERE HAVE BEEN DISCUSSIONS REGARDING IF THE REPORTED ISSUE IS BEING CAUSED BY A GRANULOMA IN THE STOMA, BUT NO TREATMENT FOR GRANULOMA (PRESCRIPTION DROPS) HAS BEEN PROVIDED YET. CULTURES TAKEN FROM THE STOMA WERE POSITIVE FOR CANDIDA AND THEREFORE A DIFLUCAN MIXTURE WAS PRESCRIBED. THE DEVICE WAS CHANGED OUT "FROM A SLIGHTLY TOO SHORT 12 FR TO 14 FR IN THE RIGHT LENGTH" AND THERE HAVE BEEN NO FURTHER ISSUES WITH THE TUBE B

  Patient problems: Fungal Infection; Granuloma; Pain

  MAUDE report 13545922 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED AMOXICILLIN FOR AN INFECTION AT THE STOMA SITE. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 10897261 ↗