Aerin Medical, Inc. recalls Aerin Medical VivAer Stylus

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.

The recalling firm issued emails on 11/12/2024. It was necessary to notify several consignees by mail with an "URGENT: MEDICAL DEVICE FIELD NOTICE" letter dated 11/20/2024. The email described the product purchased by the consignee and the reason for recall. The consignee is informed the programmed treatment time will be shorter than the recommended 30 second treatment time for VivAer and the use of the device may result in insufficient treatment. Under the heading "Action to be Taken," it says if a defective device is identified or the consignee wishes to return unused devices within this production lot, they are to return them to the recalling firm, and return instructions are provided. Regarding the mailed "URGENT: MEDICAL DEVICE FIELD NOTICE" letters dated 11/20/2024, they informed the consignee that some of the units in the production lot were programmed incorrectly and, in these cases, the programmed treatment time will be 12 seconds of radiofrequency energy delivery with no cooling time, not the 30 second treatment time for VivAer that includes 18 seconds of energy delivery and 12 seconds of cooling time. The letter also contains instructions to share this notification with all device users within their facility and network to ensure they are aware of this issue. This notification should also be shared with any organization where the potentially affected devices have been transferred. If you need any further information or support concerning this notification, please contact us at customerservice@aerinmedical.com or call 512-221-9956.

• FDA enforcement recordOfficial FDA database entry for Z-0808-2025
• FDA 510(k) clearance · K200300The device's official FDA premarket clearance record
• FDA device classification · GEIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Aerin Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.