Device product
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Z-0808-2025
Product summary
- Event
- Event 95832
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 479 units
- Official record key
device-enforcement:Z-0808-2025
Official wording
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.
Code information: Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.