AVANOS 42735Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770427355), received between Sep 14, 2021 and Sep 17, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  Patient problems: Ulcer

  MAUDE report 50810010 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW (B)(4) THE FOLLOWING: PATIENT WITH NEW MICKEY GASTR[OST]OMY TUBE (GT) INSERTED TODAY. UPON ARRIVAL AND THROUGHOUT SHIFT-MICKEY BUTTON WAS IN PLACE, WITH THREE SUTURE/BUTTONS IN PLACE. GAUZE WAS PLACED OVER THE SITE-DUE TO PATIENT HAVING ANXIETY WHEN LOOKING AT NEW GT. GAUZE WITH SCANT SEROSANGUINOUS DRAINAGE NOTED. GT VENTING. IN EVENING- DAY AND NIGHT RN HANDOFF, LIFTED GOWN TO FIND SITE WAS BLEEDING, ONE OF THE THREE BUTTONS WAS COMPLETELY DETACHED, MICKEY BUTTON WAS COMPLETELY OUT. MICKEY BALLOON WAS FOUND TO BE DEFLATED. MD NOTIFIED . EXTRA STAFF WERE CALLED TO BEDSIDE. UPON CHECKING THE BALLOON, THE BALLOON WAS STILL COMPLETELY INTACT. UNSURE OF WHERE THE FLUID IN THE BALLOON COULD HAVE GONE AS IT WAS NOTED IN THE SURGICAL NOTE THAT IS WAS INFLATED WITH 5ML STERILE WATER. 14 FRENCH 1.5CM GT KIT AT BEDSIDE, ALONG WITH A 12 FRENCH ROB-NEL CATHETER. IN ACCORDANCE TO ADVICE FROM THE GI FELLOW, THE SENIOR RESIDENT, REINSERTED A NEW MICKEY BUTTON. PATIENT WAS MEDICATED PRIOR TO PROCEDURE WITH DILAUDID PRO RE NATA (PRN) DOSE. THERE WAS NO HARM IN THIS EVENT.

  Patient problems: Anxiety

  MAUDE report 12467741 ↗