FDA Medical Device Recalls (openFDA)
Aerin Medical, Inc.: Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
- Recall number
- Z-0808-2025
- Recalling firm
- Aerin Medical, Inc.
- Product
- Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
- Status
- Open, Classified
- Initiated
- 2024-11-12
- Posted
- 2025-01-06
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 479 units
- 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.
- Lot, serial or model codes
- Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
- 510(k) numbers
- ["K200300"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3011625895
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28