AVANOS 94779Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770947792), received between Feb 5, 2020 and Jul 24, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJul 24, 2024Material Rupture; Material Rupture

  AVANOS MEDICAL INC. RECEIVED A REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2024-00130 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN PLACED IN THE PATIENT WITH INTRODUCER PLACEMENT KITS (IPK) THE BALLOON BURST AFTER ONE DAY. THEY HAD TO CHANGE IT, KEEPING THE PATIENT IN THE HOSPITAL FOR ONE MORE DAY DUE TO THE CLOSING OF THE STOMA. IT WAS NECESSARY TO GIVE MORE MEDICINES TO THE PATIENT AND CHANGE FOR A NEW PERCUTANEOUS GASTROSTOMY SOME DAYS AFTER. PER ADDITIONAL INFORMATION RECEIVED ON 4JUL2024, THE FIRST PROCEDURE WITH THE WITH INTRODUCER PLACEMENT KITS (IPK) OCCURRED ON (B)(6) 2024. THE BALLOON BURST ON (B)(6) 2024 AND WAS UNABLE TO BE REPLACED DUE TO STOMA CLOSURE. ON (B)(6) 2024, A NEW MIC FEEDING TUBE WAS PLACED WITH THE SAME INTRODUCER PLACEMENT KITS (IPK) TECHNIQUE.

  Patient problems: Stenosis

  MAUDE report 19818064 ↗
• MalfunctionFeb 5, 2020Pressure Problem; Pressure Problem

  IT WAS REPORTED THE ENTERAL FEEDING TUBE LEAKED CAUSING SKIN BREAKDOWN, "THE SIZE OF A PENCIL ERASER" WHERE THE RETENTION RING "DIGS INTO" THE PATIENT'S SKIN. THE SKIN BREAKDOWN REQUIRED TREATMENT AT AN ADVANCED WOUND CARE CLINIC WITH COLLAGEN THERAPY FOR 6-WEEKS. CURRENTLY, THE LEAKAGE "IS LESS BUT STILL THERE." THE SKIN BREAKDOWN HAS "IMPROVED" BUT THE SKIN REMAINS "PINK AND TENDER". THE PATIENT IS CURRENTLY USING DESITIN AND 4X4 GAUZE UNDER THE RETENTION RING TO HELP WITH GASTRIC LEAKAGE AND TUBE DISCOMFORT.

  Patient problems: Skin Erosion

  MAUDE report 9670401 ↗