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AVANOS 98705Recalls & reported problems

Avanos Medical, Inc. · Enteral Access Dilation System · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770987057), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 malfunction.

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

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

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionNov 9, 2021Break; Break

    IT WAS REPORTED A PIECE OF A TELESCOPING DILATOR BROKE OFF INSIDE OF A PATIENT. ADDITIONAL INFORMATION RECEIVED 14-OCT-2021 STATED THE PHYSICIAN "NOTICED WHEN PULLING THE DILATORS BACK OUT, IT WAS DIFFICULT AND THE INNERMOST ONE DID NOT CATCH ON THE SECOND ONE AS IT SHOULD HAVE AND THE SECOND ONE ADVANCED INTO THE PATIENT. UPON REMOVAL OF THE DILATORS, THE PHYSICIAN COULD BARELY SEE THE ONE THAT WAS IN THE STOMACH, ATTEMPTED TO REMOVE IT VIA SNARE (WAS UNSUCCESSFUL). THE G-TUBE WAS PLACED AND THE PATIENT WENT TO THE GI (GASTRO INTESTINAL) LAB TO HAVE THIS FOREIGN BODY REMOVED." THE BROKEN PIECE WAS REMOVED VIA ENDOSCOPY ON (B)(6) 2021. THE PATIENT WAS DOING WELL, NO COMPLICATIONS.

    Patient problems: Foreign Body In Patient

    MAUDE report 12781609 ↗

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.