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VivAer® Stylus FG1787Recalls & reported problems

Aerin Medical Inc. · 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. · Class 2

All models of VivAer Stylus (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Nov 12, 2024Class IIOpen, Classified

    Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.

    Z-0808-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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Sources and updates

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