AVANOS 44561Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770445618), received between Feb 4, 2026 and Apr 2, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Migration

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00167 FOR THE FIRST REPORT. IT WAS REPORTED THAT A "PATIENT HAD A NEW GASTROSTOMY TUBE INSERTED, AS REPLACEMENT, ON (B)(6) 2026, WITH RADIOLOGICAL CONTROL. ON THE MORNING OF (B)(6) 2026, WHILE ENTERAL FEEDING WAS BEING RESUMED, A STATE OF HYPOVIGILANCE OCCURRED. HEMODYNAMICS WERE STABLE. THERE WAS DIFFUSE ABDOMINAL CONTRACTURE. ARTERIAL BLOOD GAS ANALYSIS REVEALED A NORMAL PH BUT HYPERLACTATEMIA AT 9 MMOL/1. AN EMERGENCY ABDOMINAL CT SCAN REVEALED POOR POSITIONING OF THE GASTROSTOMY BALLOON, WHICH ENDED IN THE OMENTAL FAT, WITH THE PRESENCE OF A SHEET OF HEMOPERITONEUM SPREADING INTO THE DOUGLAS POUCH AND SUPRAMESOCOLIC PNEUMOPERITONEUM. THE PATIENT IS TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT AND THEN TAKEN OVER BY THE DIGESTIVE SURGERY TEAM ON THE SAME DAY. PERITONITIS IN ALL FOUR QUADRANTS WAS CONFIRMED WITH THE PRESENCE OF ENTERAL FEEDING FLUID ASSOCIATED WITH FALSE MEMBRANES IN THE PELVIS. THE GASTROSTOMY TUBE WAS FOUND IN THE FREE PERITONEUM AND NOT IN THE STOMACH.

  Patient problems: Abnormal Blood Gases; Peritonitis; Septic Shock

  MAUDE report 24765645 ↗
• MalfunctionApr 2, 2026Material Rupture; Expulsion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00167 FOR THE FIRST REPORT. REFER TO 9611594-2026-00168 FOR THE SECOND REPORT. IT WAS REPORTED THAT AN 82-YEAR-OLD PATIENT BEING TREATED FOR SPONDYLODISCITIS UNDERWENT GASTROSTOMY TUBE PLACEMENT ON (B)(6) 2026. A FEW HOURS LATER, THE TUBE WAS FOUND IN HIS BED WITH THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765605 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED, ¿A 70-YEAR-OLD PATIENT UNDERWENT GASTROSTOMY PLACEMENT ON (B)(6) 2025. UPON RETURNING HOME ON (B)(6) 2025, THE FEEDING TUBE COMPLETELY DETACHED FROM THE INSIDE. CURRENT PATIENT STATUS: THE PATIENT HAS BEEN RE-HOSPITALIZED TO CLOSE THE GASTROSTOMY OPENING.¿

  Patient problems: Feeding Problem

  MAUDE report 24259127 ↗