RhinAer StylusRecalls & reported problems across all models

We found 3 models of RhinAer Stylus by Aerin Medical Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2021 and Sep 18, 2026 — classified as 31 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RhinAer Stylus problems

RhinAer Stylus models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RhinAer® Stylus FG1393

  Electrosurgical, Cutting & Coagulation & Accessories
  27 reports
• RhinAer Stylus FG815

  Electrosurgical, Cutting & Coagulation & Accessories
  9 reports
• RhinAer+ Stylus FG2258

  Electrosurgical, Cutting & Coagulation & Accessories
  3 reports

Recent RhinAer Stylus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  A patient had a RhinAer procedure. Three weeks post-procedure she experienced severe bleeding from the nose. The patient presented to the emergency room and received a sphenopalatine artery ligation.

  Patient problems: Epistaxis

  MAUDE report 50819935 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Epistaxis

  MAUDE report 50698107 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED EPISTAXIS APPROXIMATELY TWO WEEKS POST-PROCEDURE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR CARE AND RECEIVED NASAL PACKING. EPISTAXIS DID NOT RESOLVE WITH NASAL PACKING AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CAUTERIZATION OF THE SPHENOPALATINE ARTERY.

  Patient problems: Epistaxis

  MAUDE report 25337384 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT 48 HOURS FOLLOWING A RHINAER PROCEDURE WITH BILATERAL EPISTAXIS. PATIENT HAD A BILATERAL SPHENOPALATINE ARTERY LIGATION AND STAYED IN THE HOSPITAL OVERNIGHT.

  Patient problems: Epistaxis

  MAUDE report 25337279 ↗
• MalfunctionApr 23, 2026Detachment of Device or Device Component

  A STYLUS TREATMENT TIP SEPARATED WHILE PERFORMING A PROCEDURE, RESULTING IN A LOOSE COMPONENT IN THE NASAL PASSAGE. THE LOOSE COMPONENT FROM THE STYLUS TIP WAS RETRIEVED AND NO INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972596 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE BACK OF THE RHINAER STYLUS TIP DETACHED FROM THE DEVICE DURING THE PROCEDURE CAUSING THE TIP TO SLIGHTLY SLIDE. THE PHYSICIAN SCOPED AND SUCTIONED THE NASAL AIRWAY. THE DETACHED COMPONENT WAS NOT RECOVERED. THE RHINAER STYLUS WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459547 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO AGGRESSIVELY TOWARD THE TIP. THE DEVICE WAS THEN INSERTED IN THE NOSE IN THE POSTERIOR NASAL NERVE AREA. WHEN PRESSURE WAS APPLIED TO THE DEVICE, THE TIP BROKE AND A FRAGMENT DETACHED FROM THE STYLUS TIP. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE COMPANY REPRESENTATIVE REVIEWED PROPER BENDING PROCEDURE FOR THE DEVICE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040028 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO CLOSE TO THE TIP AND APPLIED PRESSURE TO TIP. DURING THE PROCEDURE, THE STYLUS TIP BROKE AND A FRAGMENT DETACHED FROM THE STYLUS TIP. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040019 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A BILATERAL RHINAER PROCEDURE PERFORMED IN THE OFFICE UNDER LOCAL, TOPICAL ANESTHESIA WITH NO INJECTION. THERE WERE NO OTHER PROCEDURES PERFORMED AND IT WENT SMOOTHLY. PATIENT IS NOT ON ANTICOAGULANT MEDICATION. TEN (10) DAYS POST PROCEDURE THE PATIENT'S FAMILY MEMBER CALLED THE OFFICE AND RELAYED THAT THE PATIENT HAD CONCERNING NASAL BLEEDING FROM THE RIGHT SIDE. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE ER. THE TREATING ENT PHYSICIAN DID NOT HAVE PRIVILEGES AT THE HOSPITAL. THE RIGHT SIDE WAS PACKED WITH A RAPID RHINO BUT THE BLEEDING CONTINUED AND THE LEFT SIDE ALSO REQUIRED PACKING WITH A RAPID RHINO. THE PATIENT REQUIRED A BLOOD TRANSFUSION AND WAS ADMITTED OVERNIGHT. THE PATIENT WAS RELEASED THE NEXT MORNING WITH INSTRUCTION TO FOLLOW UP WITH TREATING ENT PHYSICIAN IN 2-3 DAYS, BUT STARTED BLEEDING AGAIN BEFORE THIS APPOINTMENT. THE ENT PHYSICIAN TOOK HIM TO THE OR AND WAS ABLE TO VISUALIZE A BLEEDING BRANCH OF THE SPA ON THE RIGHT SIDE. THE LOCATION OF THE BLEED WAS CAUTERIZED AND A MEROCEL PACK WAS PLACED. THE PATIENT WAS AGAIN ADMITTED OVERNIGHT. THE SMALL PACKING WAS REMOVED THE NEXT MORNING, NO FURTHER BLEEDING WAS NOTED. THE PATIENT WAS DI

  Patient problems: Epistaxis; Perforation

  MAUDE report 22527489 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT UNCOMPLICATED TREATMENT WITH RHINAER STYLUS. 2.5 WEEKS POST-PROCEDURE THE PATIENT PRESENTED TO LOCAL EMERGENCY ROOM WITH BLEEDING INTO THE OROPHARYNX AND OUT THE LEFT NARIS. A SYNCOPAL EPISODE AND CONCERNS OF HEMODYNAMICS WERE NOTED. THE PATIENT WAS PACKED WITH A BALLOON, GIVEN 1 UNIT OF BLOOD AND TRANSFERRED TO ANOTHER HOSPITAL. PATIENT WAS TAKEN TO THE OR. SPHENOPALATINE ARTERY LIGATION WAS PERFORMED TO ACHIEVE HEMOSTASIS. ENDOSCOPIC INSPECTION OF CONTRALATERAL (RIGHT) SIDE SHOWED NO SIGNS OF MUCOSAL INTERRUPTION OR TRAUMA IN THE AREA OF AN ACCESSORY ARTERIAL BRANCH WITH VERY HEALTHY TISSUE SURROUNDING IT AND GOOD VIABLE MUCOSA. PATIENT WAS SEEN 5 DAYS POST-PROCEDURE AND NO FURTHER ISSUES REPORTED.

  Patient problems: Epistaxis

  MAUDE report 22465346 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AERIN REPRESENTATIVE REPORTED THAT THE PHYSICIAN BENT THE STYLUS SHAFT TOO CLOSE TO THE TIP AND APPLIED TOO MUCH PRESSURE DURING USE. THE TIP BROKE. THE LOOSE COMPONENT WAS RETRIEVED FROM THE NASAL PASSAGE. NO PATIENT INJURY OR COMPLICATION WERE REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22343136 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  RHINAER STYLUS WAS USED IN A PROCEDURE. THE NURSE EXPLAINED THAT THE BACKSIDE OF THE TREATMENT TIP (THE GREY CASING) BROKE OFF DURING THE PROCEDURE TOWARDS THE END OF THE PROCEDURE. THE PHYSICIAN RETRIEVED THE PIECE WITH A STRAIGHT BLAKESLEY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057704 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED BILATERALLY WITH RHINAER STYLUS IN THE OFFICE UNDER LOCAL ANESTHESIA. THE PATIENT PRESENTED TO THE OFFICE 5 DAYS POST-PROCEDURE WITH BRISK BLEEDING THAT WAS NOT ABLE TO BE CONTROLLED IN THE OFFICE SETTING. THE PATIENT WAS TAKEN TO THE OR WHERE A BLEED FROM A BRANCH OF THE RIGHT SPA WAS CONTROLLED WITH CAUTERY. THE PATIENT HAD VOMITED A LARGE AMOUNT OF BLOOD AND FOR SAFETY WAS INTUBATED AND KEPT IN THE ICU OVERNIGHT. THE PATIENT REQUIRED TRANSFUSION OF PRBCS (PACKED RED BLOOD CELLS) AND FFP (FRESH FROZEN PLASMA). THE NEXT DAY THE PATIENT WAS STABLE, EXTUBATED AND SENT HOME. THE PATIENT HAD ANOTHER BRISK, BUT NOT AS SEVERE, BLEED 4 DAYS LATER (9 DAYS POST-PROCEDURE) FROM THE LEFT SIDE. THE PATIENT WAS PACKED IN THE ED TO TEMPORARILY CONTROL THE BLEED, THEN TAKEN TO THE OR WHERE THE BLEED, NEAR THE ATTACHMENT OF THE LEFT MIDDLE TURBINATE, WAS CONTROLLED WITH CAUTERY. A SMALL, LESS SIGNIFICANT BLEED ON THE RIGHT, IN A DIFFERENT SPOT THAN PREVIOUSLY TREATED, WAS ALSO CAUTERIZED. THE PATIENT WAS KEPT OVERNIGHT, DID WELL AND THEN WAS SENT HOME. THE PATIENT FOLLOWED UP 14 DAYS POST-PROCEDURE AND WAS DOING WELL.

  Patient problems: Epistaxis

  MAUDE report 22040092 ↗
• MalfunctionMay 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TREATMENT TIP OF THE RHINAER STYLUS SEPARATED DURING TREATMENT OF THE TURBINATE AT THE END OF PROCEDURE. THE HOUSING FOR THE ELECTRODES DETACHED FROM STYLUS. THE COMPONENT FELL ONTO THE "FLOOR OF THE NOSE" RIGHT BY THE ENTRANCE TO THE NOSE / NOSTRIL. THE BROKEN COMPONENT WAS EASILY IDENTIFIABLE BY THE PHYSICIAN AND WAS EASILY REMOVED. THE PROCEDURE COMPLETED AS PLANNED. NO PATIENT INJURY OR ISSUES REPORTED DUE TO THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21957357 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN PERFORMED AN UNEVENTFUL RHINAER PROCEDURE ON THE PATIENT. TOPICAL ANESTHESIA WAS USED. PATIENT HAD A FOLLOW UP ONE WEEK AFTER THE PROCEDURE WITH A MID LEVEL PROVIDER AND HAD NO UNUSUAL CONCERNS AT THAT TIME. SECOND FOLLOW UP WAS WEEK TWO WITH TREATING PHYSICIAN, A FLEXIBLE RHINOLARYNGOSCOPY WITH DEBRIDEMENT WAS DONE. A SMALL AMOUNT OF BLEEDING WAS NOTED WITH CRUST REMOVAL BUT THE BLEEDING WAS SELF-LIMITED. ONE DAY LATER THE PATIENT COMPLAINED OF OOZING. THE PATIENT REPORTED FEELING FAINT, SAT DOWN AND HIT HER HEAD. THE PATIENT PRESENTED TO A NEARBY ED. A CT SCAN WAS PERFORMED (NO REPORT OF SIGNIFICANCE) AND THE PATIENT REQUIRED A PARIETAL LACERATION REPAIR WITH 10 STAPLES. THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH CARDIOLOGY. AT THIS TIME NOTHING WAS REQUIRED FOR EPISTAXIS AND PATIENT WAS SENT HOME. THE NEXT MORNING THE PATIENT HAD SIGNIFICANT EPISTAXIS AND WENT BACK TO THE SAME ED. BILATERAL ANTERIOR BALLOON PACKS WERE PLACED AND THERE CONTINUED TO BE SOME OOZING. THE TREATING ENT PHYSICIAN SPOKE WITH THE ED DOCTOR AND ACCEPTED TRANSFER TO TREATING PHYSICIAN'S ED. ONCE AT HOSPITAL, TXA WAS GIVEN AND THE BLEEDING STOPPED. AN ECG REVEALED A RIGHT BUNDLE BRANCH BLOCK

  Patient problems: Epistaxis; Perforation

  MAUDE report 21607678 ↗

Other Aerin Medical Inc. products

• VivAer Stylus2 models · 3 reports · 1 recall