AVANOS 42698Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770426983), received between Mar 1, 2023 and Sep 23, 2026 — classified as 2 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• OtherSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872974 ↗
• InjuryNov 8, 2024Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED, "FOURTEEN-MONTH-OLD INFANT WITH A LONG HISTORY OF PREMATURITY AT 24 WEEKS' GESTATION AND SEVERE BRONCHOPULMONARY DYSPLASIA, SUFFERING FROM ORAL DYSFUNCTION. ON (B)(6) 2024, A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WAS PERFORMED, FOLLOWED BY LAPAROSCOPIC ANTI-REFLUX SURGERY ACCORDING TO TOUPET ON (B)(6) 2024. DURING THIS SURGICAL PERIOD, THE OLD GASTROSTOMY WAS UNHOOKED AND A NEW LAPAROSCOPIC GASTROSTOMY CREATED. TWO MONTHS LATER, DESPITE IN-PATIENT CARE AND CHANGES IN CARE PROTOCOLS, RECURRENT DIFFICULTIES IN HEALING THE GASTROSTOMY ORIFICE WERE NOTED. THE GASTROSTOMY ORIFICE REGULARLY LEAKED, REQUIRING REGULAR DRESSING CHANGES, AND SKIN IRRITATION WAS DIFFICULT TO TREAT, DESPITE PERIODS OF IMPROVEMENT. BASED ON THESE FACTORS AND GIVEN THE IMPACT ON THE CHILD'S COMFORT AND THE PRESENCE OF MULTI-RESISTANT GERMS IDENTIFIED ON LOCAL BACTERIOLOGICAL SAMPLES, AFTER DISCUSSION WITH THE PAEDIATRIC TEAM (GASTRO, NUTRITION AND INFECTIOLOGY), IT WAS DECIDED TO PROCEED WITH A COMPLETE REPAIR OF THIS GASTROSTOMY. OPERATION ON (B)(6) 2024 UNDER ANAESTHESIA TO PLACE THE NEW GASTROSTOMY WITH MICKEY BUTTON IMPLANTATION. THE OPERATION WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED TO

  Patient problems: Drug Resistant Bacterial Infection; Skin Inflammation/ Irritation

  MAUDE report 20645027 ↗
• InjuryJul 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED, FEEDING TUBE LEAKS AND REQUIRE FREQUENT TUBE CHANGES WHICH HAVE CAUSED INFLAMMATION TO THE PATIENT¿S STOMA. PATIENT WAS TREATED WITH ANTIBIOTICS FOR ONE WEEK FROM (B)(6) 2024. PATIENT WAS ALSO PRESCRIBED FLAMINAL HYDRO GEL DRESSING ON THE ((B)(6) 2024. CURRENTLY THE SITE LOOKS BETTER AND THE PATIENT DID RESPOND WELL TO THE ANTIBIOTICS. PATIENT¿S STOMA SITE CURRENTLY RED AND SORE. LEAKAGE IS REDUCED WITH DRESSINGS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19740315 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED THE GASTROSTOMY TUBE BROKE OFF INSIDE OF THE CHILD AT DAYCARE. THE TUBE BROKE APART AND WAS TOLD THAT PART OF IT WAS STILL INSIDE BUT WAS REMOVED BY THE CAREGIVER. EMAIL FROM REP VIA CUSTOMER "RECENTLY, I HAD GOTTEN A CALL FROM (B)(6). THEY HAVE HAD 3 OF HIS G-TUBE'S BREAK PER MOM. HE HAD ONE FOR 3 DAYS THAT WAS SHIPPED ON (B)(6) 2023. MOM SAID IT BROKE OFF INSIDE OF THE CHILD AT DAYCARE. I WANTED TO SEE IF WE CAN REACH OUT THE MANUFACTURER ABOUT THIS ISSUE TO HELP WITH SENDING OUT A NEW ONE FOR THEM. SHE DOES NOT HAVE A BACKUP AND THE CHILD CANNOT GO TO DAYCARE WITH OUT ONE. IN ADDITION, I WANTED TO LET BOB KNOW ABOUT THIS SINCE HE IS SEEN AT AL DUPONT HOSPITAL. MOM SAID THEY ARE SEEING THE SURGEON NEXT WEEK TO SEE IF THERE ARE ISSUES WITH THE SIZE OF THE TUBE. I NEED TO CALL MOM BACK TODAY AND WOULD LIKE TO HAVE A PLAN FOR HER. CAN YOU PLEASE ASSIST ME WITH THIS. I CAN SEND ONE OUT BUT WE WANTED TO SEE IF THE MANUFACTURER WILL COVER THIS COST. IF YOU CAN LET ME KNOW BY NOON, IT WOULD BE GREAT SO I CAN CALL HER AND GET THE TUBE SENT OUT TODAY IF POSSIBLE. THE ITEM NUMBER IS AVA-81401210. IT IS A 12 FR WITH 1.0 CM"-ABARRETT EMAIL FROM CUSTOMER IN RESPONSE TO "MOM SA

  Patient problems: Foreign Body In Patient

  MAUDE report 16463393 ↗