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RhinAer Stylus

Aerin Medical Inc. · Model FG815 · UDI-DI 08886479300184

GEI Prescription

510(k) clearances

118,289

Adverse events (469 deaths)

644

Recalls

858

Facilities

Description

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 is 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. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis. The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only.

Recalls

Date	Firm	Reason
2026-08-18	Olympus Corporation of the Americas	Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2026-06-08	Stryker Corporation	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-08	Stryker Corporation	There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2026-06-02	Maquet Cardiovascular, LLC	Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-2878
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-03-23	Olympus Corporation of the Americas	Potential for detachment of a distal tip component of the device during use.
2026-02-25	Olympus Corporation of the Americas	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For
2026-02-25	Olympus Corporation of the Americas	Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting For

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.