RhinAer+ Stylus FG2258Recalls & reported problems
Aerin Medical Inc. · The RhinAer+ Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer+ Stylus consists of a handle, shaft, and treatment tip. An array of bipolar electrodes are positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. · Class 2
All models of RhinAer Stylus (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08886479300306), received between May 29, 2026 and Sep 18, 2026 — classified as 3 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Epistaxis3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A patient had a RhinAer procedure. Three weeks post-procedure she experienced severe bleeding from the nose. The patient presented to the emergency room and received a sphenopalatine artery ligation.
Patient problems: Epistaxis
MAUDE report 50819935 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Epistaxis
MAUDE report 50698107 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED EPISTAXIS APPROXIMATELY TWO WEEKS POST-PROCEDURE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR CARE AND RECEIVED NASAL PACKING. EPISTAXIS DID NOT RESOLVE WITH NASAL PACKING AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CAUTERIZATION OF THE SPHENOPALATINE ARTERY.
Patient problems: Epistaxis
MAUDE report 25337384 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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