Vivaer ARC Stylus FG257Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08886479300146), received between Jan 28, 2021 and Jan 28, 2021 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PROCEDURE TO ADDRESS NASAL AIRWAY OBSTRUCTION WITH VIVAER ARC STYLUS. THE NASAL VALVE AREA INCLUDING THE LATERAL NASAL WALL FOR BOTH LEFT AND RIGHT NOSTRILS WERE TREATED. DURING THE 90 DAYS POST PROCEDURE FOLLOW UP, A MASS WAS NOTICED IN THE TREATED AREA ON THE RIGHT LATERAL WALL OF THE NASAL VALVE. NO ISSUES WERE REPORTED REGARDING THE TREATED AREA IN THE LEFT NOSTRIL. AERIN MEDICAL WAS INFORMED NO MEDICAL INTERVENTION IS REQUIRED. AERIN MEDICAL CONTINUED TO FOLLOW UP WITH THE CLINIC. HOWEVER, NINE (9) DAYS LATER THE CLINIC MENTIONED THAT A PROCEDURE WOULD BE SCHEDULED TO REMOVE THE MASS. THE MASS WAS REMOVED THE FOLLOWING WEEK AND SENT FOR PATHOLOGY EXAMINATION. THE PATHOLOGY RESULTS SHOWED FIBROTIC SOFT TISSUE (SCAR TISSUE). THE PHYSICIAN FURTHER CONFIRMED THAT THE PATIENT IS FINE. THERE WAS NO REPORT OF DEVICE MALFUNCTION BY THE CLINIC.

  Patient problems: Scar Tissue

  MAUDE report 11243343 ↗