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VivAer Stylus recallZ-0808-2025 · Aerin Medical, Inc. · initiated Nov 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aerin Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] or call 512-221-9956.

Recall details

Recall number
Z-0808-2025
Status
Open, Classified
Initiated by the company
Nov 12, 2024
Posted by the FDA
Jan 6, 2025
Recalling firm
Aerin Medical, Inc.
Quantity
479 units
Product code
GEI
FDA submissions
K200300
Distribution
US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV.

Product description

Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

Code information (models, lots, serial numbers)

Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K200300 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page