AVANOS 95487Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770954875), received between Mar 5, 2021 and Mar 5, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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. Jan 16, 2024Open, Classified

   MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

   Z-1187-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionMar 5, 2021Fracture; Fracture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2021-00032 FOR THE FIRST EVENT. REFER TO 9611594-2021-00034 FOR THE THIRD EVENT. IT WAS REPORTED THE TUBES FRACTURED DOWN WHERE THE G-TUBE AND J-TUBE CONNECT. THE PATIENT CALLED AND SAID WHEN THEY WENT TO IRRIGATE THE J-PORT, THERE WAS RETURN VIA THE G PORT. WHEN IT WAS REPLACED IN THE IRL, IT WAS NOTED THAT THE "SIDE WALL WAS BLOWN OUT ON THE TUBE IN THE DISTAL PORTION (IN STOMACH)". THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11422898 ↗
• MalfunctionMar 5, 2021Fracture; Fracture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2021-00032 FOR THE FIRST EVENT. REFER TO 9611594-2021-00033 FOR THE SECOND EVENT. IT WAS REPORTED THE TUBES FRACTURED DOWN WHERE THE G-TUBE AND J-TUBE CONNECT. THE PATIENT CALLED AND SAID WHEN THEY WENT TO IRRIGATE THE J-PORT, THERE WAS RETURN VIA THE G PORT. WHEN IT WAS REPLACED IN THE IRL, IT WAS NOTED THAT THE "SIDE WALL WAS BLOWN OUT ON THE TUBE IN THE DISTAL PORTION (IN STOMACH)". THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11422863 ↗
• MalfunctionMar 5, 2021Fracture; Fracture

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2021-00033 FOR THE SECOND EVENT. REFER TO 9611594-2021-00034 FOR THE THIRD EVENT. IT WAS REPORTED THE TUBES FRACTURED DOWN WHERE THE G-TUBE AND J-TUBE CONNECT. THE PATIENT CALLED AND SAID WHEN THEY WENT TO IRRIGATE THE J-PORT, THERE WAS RETURN VIA THE G PORT. WHEN IT WAS REPLACED IN THE IRL, IT WAS NOTED THAT THE "SIDE WALL WAS BLOWN OUT ON THE TUBE IN THE DISTAL PORTION (IN STOMACH)". THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11422858 ↗