Aerin Medical, Inc. is recalling 479 units of the VivAer Stylus (REF CAT1785 and CAT500) because some units in a single production lot were programmed incorrectly. This error causes the Aerin Console to incorrectly identify the VivAer Stylus as a RhinAer Stylus when connected. No incidents or injuries have been reported to date, but the manufacturer is initiating this recall to ensure devices perform as intended during clinical procedures.
If the stylus is incorrectly recognized by the console, it could lead to improper device performance or delays in medical procedures. This software recognition error prevents the system from functioning as expected, which could potentially impact the quality of patient care.
UDI: (01)08886479300269(17)260501(10)10235; Recall #: Z-0808-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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