VivAer® Stylus FG722Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08886479300160), received between Aug 26, 2022 and Mar 5, 2025 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K200300); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH EXTERNAL NASAL VALVE COLLAPSE AND LOWER LATERAL CARTILAGE STENOSIS. THE PHYSICIAN TREATED THE LOWER LATERAL CARTILAGE AND ALAR CARTILAGE WITH THE VIVAER STYLUS AND REPORTED OVERLAPPING SOME TREATMENTS. THE PATIENT RETURNED FOR FOLLOW UP AFTER A PERIOD OF SEVERAL MONTHS WITH ABSORPTION OF A PORTION OF THE LOWER LATERAL CARTILAGE AND WORSENING OF THE EXTERNAL NASAL VALVE COLLAPSE. APPROXIMATELY 14 MONTHS LATER, A REVISION SURGERY WAS PERFORMED, OPEN VALVE NASAL RECONSTRUCTION. IT WAS ALSO REPORTED THAT THE PATIENT HAD TWO PREVIOUS NASAL SURGERIES INCLUDING A RHINOPLASTY. BASED ON THESE CIRCUMSTANCES, INTENTIONAL USE ERROR CAUSED AND CONTRIBUTED TO THE REPORTED EVENT. ADDITIONAL INFORMATION FROM THE PHYSICIAN STATES THEY ARE AWARE OF INDICATIONS FOR USE. AERIN MEDICAL WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

  Patient problems: Cartilage damage; Deformity/ Disfigurement

  MAUDE report 21532491 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED VIVAER TREATMENT OF THE INFERIOR TURBINATES AND SWELL BODIES ON (B)(6) 2023. APPROXIMATELY 1 MONTH POST TREATMENT ((B)(6) 2023) THE PATIENT EXPERIENCED A SEVERE NOSEBLEED AND WENT TO THE EMERGENCY ROOM AND HAD EMBOLISM OF THE SPA DONE TO STOP THE BLEEDING AND SPENT 5 DAYS IN THE HOSPITAL. THE PATIENT REPORTED THAT THEY LOST NEARLY 2 PINTS OF BLOOD AND THAT SHE WAS RECOVERING BUT IN PAIN AND THEIR THROAT WAS IRRITATED FROM THE INTUBATION TUBE. APPROXIMATELY 1 WEEK LATER, THE PATIENT EXPERIENCED A SECOND NOSEBLEED AND RETURNED TO THE EMERGENCY ROOM. A CEREBRAL ANGIOGRAM WAS PERFORMED, AND THE PATIENT HAD EMBOLIZATION OF THE SPA REPEATED TO STOP THE BLEEDING. THE PATIENT IS RECOVERING.

  Patient problems: Epistaxis

  MAUDE report 18490156 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT WAS TREATED WITH THE VIVAER STYLUS ONLY ON THE RIGHT SIDE. THE SWELL BODY, INTERNAL NASAL VALVE AND THE INFERIOR TURBINATE WERE TREATED. PATIENT HAD FIRST FOLLOW UP VISIT ON (B)(6) 2022 AND AGAIN ON (B)(6) 2022. AT BOTH VISITS, THE PATIENT SHOWED GOOD MUCOSAL HEALING. AT THIRD FOLLOW-UP VISIT ON (B)(6) 2022, MUSCOSA WAS INTACT. PHYSICIAN DISCUSSED SEPTO-TURB OPTION WITH THE PATIENT BECAUSE PATIENT WAS STILL COMPLAINING OF CONGESTION. AT 7-MONTH FOLLOW-UP ON (B)(6) 2022, PATIENT PRESENTED WITH CRUSTING ON SEPTUM AND 1X1 CM2 MUCOSAL PERFORATION IN AREA TREATED WITH VIVAER STYLUS. CARTILAGE WAS INTACT. THE PATIENT REPORTED USING AFRIN OFF AND ON FOR PAST MONTH. PHYSICIAN PLANS TO MOVE FORWARD WITH SEPTOPLASTY PROCEDURE TO ADDRESS PERSISTENT CONGESTION. TOPICAL NASAL DECONGESTANT SPRAYS HAVE BEEN REPORTED TO CAUSE MUCOSAL PERFORATION. THE DETERIORATION OF THE MUCOSA IS PROBABLY RELATED TO THE COMBINATION OF THE RADIOFREQUENCY TREATMENT OF THE TISSUE IN THE AREA FOLLOWED BY USE OF AFRIN.

  Patient problems: Perforation

  MAUDE report 15307612 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200300. One submission often covers many models, so check the product and lot details in each record.

• Z-0808-2025 · Nov 12, 2024 · Open, Classified
  Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.