Skip to content

AVANOS 98438Recalls & reported problems

Avanos Medical, Inc. · Introducer Kit for Jejunal/Gastric Jejunal Feeding Tube · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770984384), received between Jul 17, 2020 and Jun 16, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break3

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 16, 2021Break; Break

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00082 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE SET OF STAYS [SUTURES] HAD COME DISLODGED WITHIN 24 HOURS OF PLACEMENT. PER THE REPORT, THE "TUBE WAS MOVED AND PATIENT HAD GASTRIC LEAK INTO PERITONEUM." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

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

    MAUDE report 12010946 ↗
  • InjuryJun 16, 2021Break; Break

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00083 FOR THE SECOND REPORT IT WAS REPORTED THAT THE SET OF STAYS [SUTURES] HAD COME DISLODGED WITHIN 24 HOURS OF PLACEMENT. PER THE REPORT, THE "TUBE WAS MOVED AND PATIENT HAD GASTRIC LEAK INTO PERITONEUM." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

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

    MAUDE report 12010939 ↗
  • MalfunctionJul 17, 2020Break; Break

    IT WAS REPORTED THREE T-FASTENERS WERE PLACED AND ONE BROKE DURING DILATATION. THERE WAS NO REPORTED INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10291584 ↗

Other TUBE, GASTRO-ENTEROSTOMY devices

All TUBE, GASTRO-ENTEROSTOMY devices →

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