AVANOS 98703Recalls & reported problems
Avanos Medical, Inc. · Enteral Access Dilation System · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770987033), received between Feb 23, 2023 and Feb 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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
- Device Slipped1
Patient problems
- Insufficient Information1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2023Device Slipped; Device Slipped
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2023-00024 FOR THE FIRST REPORT. IT WAS REPORTED THAT "THE DIFFERENT SHAFTS OF THE DILATORS ARE SLIDING OVER EACH OTHER EACH OTHER AND CAUSED A PERFORATION IN THE STOMACH." SURGERY WAS NEEDED TO CLOSE THE PERFORATION. MEDICATION WAS NEEDED FOR INFECTION PREVENTION, AND THE PATIENT HAD TO STAY IN THE HOSPITAL LONGER TO RECOVER. PATIENT IS CURRENTLY RECOVERING. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, ONLY ONE PATIENT WAS INVOLVED. THE PATIENT HAS RECOVERED AND HAS RETURNED HOME.
Patient problems: Insufficient Information; Perforation
MAUDE report 16428274 ↗
Other TUBE, GASTRO-ENTEROSTOMY devices
- AVANOS 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY93 reports
- AVANOS 98432Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY72 reports
- Gastrointestinal Anchor Set, SAF-T-PEXY* T-Fasteners 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death61 reports
- Halyard 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death40 reports
- Halyard 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY35 reports
- AVANOS 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY34 reports
- AVANOS 98430Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death29 reports
- Halyard 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.