AVANOS 46223Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770462233), received between Mar 6, 2023 and Oct 29, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT WHEN TRYING TO TRACTION REMOVE THE CORFLO PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] AFTER 3-MONTHS, THE INNER BUMPER GOT LOOSE AND THE TUBING CAME OUT. THE INNER BUMPER WAS STILL IN THE PATIENT. A GASTROSCOPY WAS NEEDED TO REMOVE THE INNER BUMPER. ADDITIONAL INFORMATION RECEIVED 20-OCT-2025 STATED "THE CORFLO PEG WAS INSERTED (B)(6) 2025 AND REMOVED (B)(6) 2025." THE PATIENT DIDN'T NEED A MIC-KEY BUTTON, THE PATIENT COULD EAT FOOD NORMALLY BY HIMSELF.

  Patient problems: Foreign Body In Patient

  MAUDE report 23416824 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] TUBE "INNER FIXATION STOP CAME LOOSE FROM THE TUBING WHEN TRYING TO PULL IT OUT/TRACTION REMOVE." THE DEVICE WAS IN USE FOR SIX MONTHS. ADDITIONAL INFORMATION RECEIVED 17-DEC-2024 NOTED THE CLINICIAN LEFT "STOP PLATE IN PLACE AND INFORMED THE PATIENT OF THE SYMPTOMS TO WATCH OUT FOR." ADDITIONAL INFORMATION RECEIVED (B)(6) 2024 12-19 NOTED THE PATIENT WAS "GOOD WHEN LEFT THE CLINIC, LIVING AT HOME."

  Patient problems: Foreign Body In Patient

  MAUDE report 21130025 ↗
• MalfunctionMar 6, 2023Material Separation; Material Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3006646024-2023-00013 FOR THE FIRST REPORT. REFER TO 3006646024-2023-00014 FOR THE SECOND REPORT. IT WAS REPORTED, "THE INTERNAL STOP PLATE COMES OFF AND REMAINS IN THE STOMACH AND HAS TO COME OUT THE NATURAL WAY. IT HAS HAPPENED SEVERAL TIMES." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16486871 ↗
• MalfunctionMar 6, 2023Material Separation; Material Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3006646024-2023-00013 FOR THE FIRST REPORT. REFER TO 3006646024-2023-00015 FOR THE THIRD REPORT. IT WAS REPORTED, "THE INTERNAL STOP PLATE COMES OFF AND REMAINS IN THE STOMACH AND HAS TO COME OUT THE NATURAL WAY. IT HAS HAPPENED SEVERAL TIMES." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16486868 ↗
• MalfunctionMar 6, 2023Material Separation; Material Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3006646024-2023-00014 FOR THE SECOND REPORT. REFER TO 3006646024-2023-00015 FOR THE THIRD REPORT. IT WAS REPORTED, "THE INTERNAL STOP PLATE COMES OFF AND REMAINS IN THE STOMACH AND HAS TO COME OUT THE NATURAL WAY. IT HAS HAPPENED SEVERAL TIMES." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16486863 ↗