AVANOS 95656Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770956565), received between Oct 22, 2020 and Feb 8, 2021 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 31, 2024Open, Classified

   The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

   Z-2422-2024 · Root cause: Error in labeling · FDA record ↗

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.

• MalfunctionFeb 8, 2021Break; Break

  IT WAS REPORTED THE PATIENT HAD AND ENTERAL FEEDING TUBE PLACED IN (B)(6) OF 2020 WHICH "DEVELOPED A BREAK BETWEEN THE G AND J TUBES INSIDE, AND THE FEEDING WENT INTO THE STOMACH AND LEAKED OUT OF TUBE." THERE WAS NO REPORTED INJURY BUT THE PATIENT WAS TAKEN TO THE HOSPITAL FOR TUBE REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11296819 ↗
• MalfunctionOct 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE FEEDING TUBE, "COMPLETED DETACHED 15CM FROM THE BUTTON. 30CM WAS LEFT IN THE STOMACH. TUBE IN STOMACH WAS REMOVED BY ENDOSCOPY. NO HARM CAME TO PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 10719193 ↗