Skip to content

AVANOS 44548Recalls & reported problems

Avanos Medical, Inc. · MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Endoscopic/Radiologic Placement · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770445489), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 malfunction.

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-1186-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • No Apparent Adverse Event1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED "THE PROBE HAS ALREADY BEGUN TO MALFUNCTION; IT BEGAN TO FILTER THROUGH TORTUOSITIES WHAT IS HAPPENING THROUGH THE GASTRO." IT WAS NOTED THE DEVICE APPEARS TO HAVE WHAT LOOKS LIKE INTESTINAL TISSUE MIGRATING INTO THE FEEDING TUBE CHANNEL. THE TUBE ITSELF HAS NO REPORT OF ANY DEFICIENCIES, BUT THERE IS DEFINITE FOREIGN MATERIAL IN THE TUBE CHANNEL. THE PATIENT WAS ADMINISTERED AN EXTENSIVE LIST OF MEDICATIONS THROUGH THE DEVICE. ADDITIONAL INFORMATION RECEIVED 15-AUG-2023 STATED THE PATIENT WAS AT HOME. THE DEVICE WAS FLUSHED WITH WATER 10CC BEFORE AND AFTER EACH USE. THE GASTRIC-JEJUNAL ARE BOTH USED. THE DEVICE WAS NOT ATTACHED TO SUCTION. THE EVENT OCCURRED GRADUALLY. THERE WAS NO RECORD OF THE PATIENT UNDERGOING ANY PROCEDURES PREVIOUS TO THIS INCIDENT. THERE WAS NO RECORD OF SEPARATION OF INTESTINES. THERE WAS NO RECORD OF ANY INTESTINAL WORMS. THE PATIENT IS REPORTED TO BE AN ALERT, CONSCIOUS PATIENT, ORIENTED WITH SEQUELAE OF COVID 19 BY PULMONARY FIBROSIS, WITH DEPENDENCE ON MECHANICAL VENTILATION, PERSISTENCE OF GASTROESOPHAGEAL REFLUX, BECAUSE HE REQUIRES AN ADVANCED FEEDING TUBE TO JEJUNUM. THAT PARTICULAR FEEDING TUBE HAD BEEN IN PLACE FOR APPROXIMATELY 3

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17631089 ↗

Other Tubes, gastrointestinal (and accessories) devices

All Tubes, gastrointestinal (and accessories) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.