Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Summary
The FDA issued a Class II for Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5- by Aerin Medical, Inc.. Reason: Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylu.
Details
Source
Device Recall
External ID
Z-0808-2025
Action Date
2025-01-15
Status
Ongoing
Category
device
Product Description
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Lot/Code Info: Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
Quantity Affected: 479 units
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-12
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aerin Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aerin Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aerin Medical, Inc. have FDA actions?
Aerin Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0808-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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