Audion AET-100Recalls & reported problems
Stryker Corporation · ET dilation system · Class 2
- 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 00850002250428), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN AUDION EUSTACHIAN TUBE DILATION THE PATIENT SNEEZED/COUGHED FORCIBLY AND PRESENTED WITH A SUBCUTANEOUS EMPHYSEMA IN THE NECK AREA. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR OBSERVATION AND KEPT OVERNIGHT. NO ADDITIONAL MEDICAL INTERVENTION WAS TAKEN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15903802 ↗
Other Eustachian Tube Balloon Dilation Device devices
- ACCLARENT AERA EU061655Acclarent, Inc. · Eustachian tube balloon dilation device10 reports
- XprESS Ultra MSB&LLFStryker Corporation · Eustachian Tube Balloon Dilation Device2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.