AVANOS 46941Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770469416), received between Feb 26, 2024 and Dec 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ¿A 52-YEAR-OLD PATIENT WAS HOSPITALIZED ON (B)(6) 2025, FOR A GASTROSTOMY TUBE REPLACEMENT. CHRONOLOGY OF EVENTS: (B)(6) 2025: INITIAL PLACEMENT OF A CORFLO GPE GASTROSTOMY TUBE USING THE PULL TECHNIQUE. THE ENDOSCOPY NURSES PROVIDED THE PATIENT'S NURSES WITH INFORMATION REGARDING GASTROSTOMY CARE. (B)(6) 2025: A FOLLOW-UP APPOINTMENT WITH THE PHYSICIAN AT 3 WEEKS WAS SCHEDULED. DURING THIS APPOINTMENT, A SKIN EROSION AROUND THE GASTROSTOMY SITE WAS OBSERVED, DUE TO PRESSURE FROM THE EXTERNAL FLANGE. A HYDROCOLLOID DRESSING WAS APPLIED TO THE EROSION, AND A PRESCRIPTION WAS ISSUED TO CONTINUE CARE. THE TUBE'S SKIN FIXATION SYSTEM IS A RIGID CLIP SYSTEM, DIFFICULT TO DISLODGE. THE PATIENT WAS GIVEN THE TUBE SUPPLIER'S INFORMATION BOOKLET. (B)(6) 2025: FOLLOWING A CONSULTATION WITH A HEPATOLOGIST, IT WAS NOTED THAT THE GASTROSTOMY OPENING WAS INFLAMED AND PAINFUL. (B)(6) 2025: THE GASTROSTOMY TUBE WAS CHANGED TO A STANDARD BALLOON TUBE WITH A FLANGED FIXATION SYSTEM. PATIENT'S CURRENT CONDITION: SIGNIFICANT LESIONS AT THE GASTROSTOMY SITE. REOPERATION FOR TUBE REPLACEMENT IN A FRAIL PATIENT. THE PATIENT IS CURRENTLY HOSPITALIZED IN A VASCULAR REHABILITATION UNIT (IN

  Patient problems: Localized Skin Lesion; Pain; Skin Inflammation/ Irritation

  MAUDE report 23827761 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  IT WAS REPORTED, IN THE DIGESTIVE EXPLORATION DEPARTMENT, WHEN THE PROBE WAS BEING REMOVED, THE RETAINING BUMPER BROKE OFF. THE RETAINING BUMPER FELL INTO THE STOMACH. A FORCEPS EXTRACTION WAS PERFORMED, PROLONGING THE OPERATING TIME. THIS WAS AN ISOLATED INCIDENT. NO INJURY REPORTED. PATIENT WAS REPORTED TO BE OK.

  Patient problems: Foreign Body In Patient

  MAUDE report 18782074 ↗