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VivAer® Stylus

Aerin Medical Inc. · Model FG1787 · UDI-DI 08886479300269

GEI Prescription

510(k) clearances

118,289

Adverse events (469 deaths)

644

Recalls

855

Facilities

Description

The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a nonconductive tip which is attached to a handle via a nonconductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a Temperature controlled radiofrequency generator (Aerin Console) via a flexible cable.

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.