AVANOS 42727Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00350770427270), received between Dec 16, 2020 and Feb 25, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Leak/Splash

  IT WAS REPORTED, ¿WE CHANGED ONE OF OUR PATIENT'S BUTTONS LAST WEEK, AND IT WAS LEAKING A LOT OF MILK WHICH CAUSED THEIR SITE TO WORSEN. IT APPEARS TO BE A VALVE ISSUE AS THE BALLOON WAS INTACT.¿ PER ADDITIONAL INFORMATION RECEIVED ON 30-JAN-2026, "THE PATIENT'S GASTROSTOMY SITE IS BEING CLEANED WITH PRONTOSAN LIQUID, THEN WE ARE APPLYING URGOTUL AG AND KLINIDERM DRESSINGS. THESE ARE ALL PRESCRIBED FROM THE PATIENT'S GP [GENERAL PRACTITIONER]. WE WERE USING THESE BEFORE THE ISSUE WITH THE BUTTON AS THE SITE WAS ALREADY BROKEN DOWN, BUT THE LEAKAGE FROM THE BUTTON MADE IT WORSE.¿

  Patient problems: Insufficient Information

  MAUDE report 24445742 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THE PARENT OF THE PATIENT REPORTED THAT SHE WENT TO CHECK ON THE PATIENT AS SHE SAW THE PATIENT GRAB NEAR THE GASTROSTOMY TUBE DURING A FEED. THE PARENT NOTICED THE PATIENT HAD THE GASTROSTOMY TUBE EXTENSION IN HER HAND AND THE GASTROSTOMY TUBE ¿TOP¿ WAS ATTACHED BUT THE BOTTOM STEM WAS NOT CONNECTED. THE PARENT WAS UNABLE TO FIND THE BOTTOM PORTION OF THE GASTROSTOMY TUBE SO SHE TOOK THE PATIENT TO THE EMERGENCY ROOM TO REPLACE THE GASTROSTOMY TUBE AS THEY DID NOT HAVE A BACKUP, AND THE PARENT COULD NOT FIND THE BOTTOM PORTION. THE EMERGENCY ROOM PHYSICIANS DID NOT BELIEVE THE PIECE WAS IN THE PATIENT'S STOMACH AFTER THEY DID TESTS. THE PARENT SAID THE PHYSICIANS TOOK X-RAYS AND ANOTHER SCAN. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028177 ↗
• InjuryJul 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED, GASTRONOMY SITE LEAKING AND SURROUNDING SKIN RED. PATIENT DEVELOPED GRANULOMA. SMALL MUSHROOM TYPE GROWTH ON SHAFT. CHILD WELL IN HERSELF. NO PYREXIA, VOMITING OR OTHER SYMPTOMS. DEVICE ORIGINALLY PLACED IN HOSPITAL. CHANGED EVERY 4 MONTHS BY PARENTS. PER ADDITIONAL INFORMATION RECEIVED ON 02JUL2024, THE DEVICE WAS REPORTED AS PLACED IN (B)(6), THE PROBLEM WAS NOTICED ON (B)(6) 2024 AND WAS SUBSEQUENTLY REMOVED ON (B)(6) 2024. PER ADDITIONAL INFORMATION RECEIVED ON 03JUL2024, ¿THE SKIN SWAB GREW LIGHT GROWTH OF YEAST AND MODERATE GROWTH OF STAPHYLOCOCCUS AUREUS. PRELIMINARY RESULT SHOWS THE ASPIRATE HAS GROWN YEASTS. GRAM NEGATIVE BACILLI. CULTURE MIXED GROWTH INCLUDING HEAVY GROWTH OF CANDIDA ALBICANS. ONE OF OUR PAEDIATRIC CONSULTANTS PRESCRIBED APPROPRIATE TREATMENT, BOTH TOPICAL AND SYSTEMIC. THE PATIENT IS WELL IN HERSELF.¿.

  Patient problems: Bacterial Infection; Erythema; Fungal Infection; Granuloma; Skin Infection

  MAUDE report 19862283 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S MOM, THE PATIENT¿S STOMA SITE DEVELOPED A RASH. NYSTATIN CREAM WAS REPORTED TO BE ON THE WAY FOR TREATMENT. NO INJURY REPORTED.

  Patient problems: Rash

  MAUDE report 18244239 ↗
• InjuryOct 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE GASTROSTOMY BUTTON BURST. THERE WERE NO INJURIES REPORTED, HOWEVER, IT WAS ALLEGED THAT THE PATIENT REQUIRED A HOSPITAL STAY OF AT LEAST 8 DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12578381 ↗
• MalfunctionSep 15, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED: DEFECT OR MALFUNCTION, BALLOON TO G-TUBE FOUND TO HAVE A LEAK. LOW PROFILE G-TUBE BECAME DISLODGED. BALLOON FOUND TO HAVE A LEAK. SITUATION: I RECEIVED A TEXT MESSAGE FROM THE SURGERY RESIDENT IN AFTERNOON, THAT THE PATIENT'S G-TUBE SUTURES WERE REMOVED. PATIENT'S MOTHER CALLED OUT THAT THE G-TUBE CAME DISLODGED. BACKGROUND: PATIENT WAS POD2 (SECOND POST OP DAY) FROM G-TUBE PLACEMENT. SHE WAS SCHEDULED TO GO HOME IN THE AFTERNOON AFTER HER SECOND BOLUS FEED. MOM VOICED SHE HAD G-TUBE TEACHING THE DAY PRIOR AND FELT COMFORTABLE GOING HOME IF SHE TOLERATED HER PM G-TUBE BOLUS FEED. RESIDENT TEXTED ME THAT THE PATIENT'S G-TUBE SUTURES WERE REMOVED. AT THAT TIME, I WAS WITH ANOTHER PATIENT. WHEN I EXITED MY OTHER PATIENT'S ROOM, THE UNIT SECRETARY TOLD ME THAT MOM CALLED OUT THAT HER DAUGHTER'S G-TUBE FELL OUT AND THE CHARGE NURSE WAS IN THE ROOM. WHEN I GOT TO THE PATIENT'S ROOM, THE OLD G-TUBE WAS BEING TROUBLESHOOTED. THE MOTHER INSTILLED WATER IN THE OLD G-TUBES BALLOON AND DISCOVERED A LEAK. IT WAS THEN THAT THE NEW G-TUBE THAT WAS AT THE BEDSIDE WAS INSERTED. IT WAS INSERTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477667 ↗
• InjuryDec 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT'S PARENT THAT TWO DAYS AFTER REPLACEMENT OF THE DEVICE ON (B)(6) 2020, THE STOMA SITE BECAME RED AND SWOLLEN, AND IV ANTIBIOTICS WERE PRESCRIBED. THE SITE IMPROVED, HOWEVER, TODAY, (B)(6) 2020, THE PARENT REPORTS THAT THE SITE HAS SWOLLEN UP AGAIN. THE PATIENT HAS HAD A FEEDING TUBE FOR TWO YEARS, WITH FOUR TUBE CHANGES IN THAT TIME. THE PATIENT DID NOT HAVE ANY REACTIONS PRIOR TO THIS. PER ADDITIONAL INFORMATION PROVIDED BY THE PATIENT'S PARENT ON 7 DEC 2020, THE DEVICE IS THE CORRECT SIZE AND THE FIRST REACTION BEGAN ON (B)(6) 2020. THE PATIENT IS STILL EXPERIENCING ISSUES WITH THE STOMA SITE.

  Patient problems: Erythema; Local Reaction; Swelling

  MAUDE report 11021726 ↗