Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Reported: January 15, 2025 Initiated: November 12, 2024 #Z-0808-2025
Product Description
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
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.
Details
- Recalling Firm
- Aerin Medical, Inc.
- Units Affected
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.. Recalled by Aerin Medical, Inc.. Units affected: 479 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2025. Severity: Moderate. Recall number: Z-0808-2025.
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