ACCLARENT AERA EU061655Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031230880), received between Oct 10, 2017 and Sep 20, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50833711 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PHYSICIAN THAT THEY WERE INFORMED ABOUT A PATIENT THAT WAS DILATED IN OFFICE ON (B)(6) 2025, USING AN AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655), THAT WAS HEADED TO THE EMERGENCY ROOM DUE TO SUBCUTANEOUS EMPHYSEMA. IT WAS REPORTED THAT NO ACCLARENT PERSONNEL WAS PRESENT DURING THE PROCEDURE. THE PHYSICIAN INDICATED THAT THERE WAS NO MALFUNCTION OF THE DEVICE; "THE PROCEDURE WENT WELL AND THE PATIENT WENT HOME FEELING WELL". IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE ER VISIT ON (B)(6) 2025. ACCORDING TO THE PHYSICIAN, THE BALLOON WAS NOT INAPPROPRIATELY FORCED THROUGH A FALSE PASSAGE DURING BALLOON PLACEMENT. ADDITIONALLY, THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 22367377 ↗
• InjuryAug 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (ENT (EAR, NOSE & THROAT) PROCEDURE WITH ACCLARENT DEVICES (ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM) EXPERIENCED A SYNCOPE EPISODE AND WENT INTO ASYSTOLE DURING THE PROCEDURE. IT WAS REPORTED THAT THE EVENT WAS CONFIRMED BY A PHYSICIAN-ANESTHESIOLOGIST WITH A HEART RATE MONITOR. IT WAS ALSO REPORTED THAT THE PATIENT WAS REVIVED WITH MEDICATION AND OXYGEN. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS ALSO NOTED THAT THE EVENT OCCURRED WHEN THE DILATION SYSTEM¿S BALLOON WAS DILATED.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 19907764 ↗
• InjuryFeb 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM AN INTERNET RELATED SOURCE. IT WAS REPORTED BY HCP THAT HE HAS SEEN AN INCIDENCE OF PATULOUS IN CHILDREN WHEN USING THE ACCLARENT AERA DEVICE. NO FURTHER CLARIFICATION ON THE INCIDENT(S) WAS PROVIDED. THERE ARE NO REPORTED MALFUNCTIONS WITH ANY ACCLARENT DEVICES.

  Patient problems: Unspecified Ear or Labyrinth Problem

  MAUDE report 18670848 ↗
• MalfunctionJan 9, 2024Crack; Appropriate Device Problem Term/Code Not Available; Crack; Appropriate Device Problem Term/Code Not Available

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A EUSTACHIAN TUBE DILATION, WHEN USING AN ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK (EU061655, UNKNOWN LOT) DURING A PRIMARY PROCEDURE ON (B)(6) 2024 THE "SILVER GUIDE TIP CATHETER WAS NOT PROPERLY SEALED AND WAS RELEASED FROM THE ORANGE PLASTIC CONNECTOR." THE REPORTER STATED THE SILVER TIP WAS "SPINNING" AND WAS ABLE TO BE PULLED APART FROM THE ORANGE PIECE. IT WAS NOTED THAT THEY REPLACED THE BALLOON CATHETER AND THE ISSUE RESOLVED. NO OTHER ISSUE WAS REPORTED. NO NON ACCLARENT DEVICES WERE USED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 11-DEC-2023 CLARIFYING THAT THE ¿"THE SILVER GUIDE TIP" REFERS TO THE RIGHT SHAFT. THE RIGHT SHAFT WAS NOT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475154 ↗
• MalfunctionAug 24, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  THE ACCLARENT ENT CONSULTANT REPORTED THAT AN EMAIL WAS RECEIVED RELATED TO AN ISSUE WITH AN ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / 221130A-PC). IT WAS REPORTED THAT A HAIR WAS NOTED INSIDE THE PACKAGING OF THE AERA BALLOON BEFORE THE DEVICE PACKAGE WAS OPENED; IT WAS CONFIRMED AFTER THE PACKAGE WAS OPENED. THE FACILITY DISCARDED THE DEVICE AND REPLACED THE AERA BALLOON. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17619033 ↗
• InjuryMay 4, 2023Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL THAT THE PATIENT UNDERWENT A PRIMARY EUSTACHIAN TUBE DILATION ON (B)(6) 2023 USING AN ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / LOT# UNKNOWN). AT THE TIME OF THE PROCEDURE, THERE WERE NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2023, THE PATIENT RETURNED TO THE CLINIC REPORTING OF LEFT EAR DISCOMFORT AND ITCHINESS. IT WAS CONFIRMED THAT A BLUE FOREIGN BODY WAS LODGED IN THE PATIENT¿S EAR CANAL. PER THE ACCLARENT ENT CONSULTANT, ¿THE TIP OF THE BALLOON DISLODGED AND EXTRUDED RETROGRADE INTO THE MIDDLE EAR AND OUT THROUGH THE MEMBRANE.¿ THE PHYSICIAN REMOVED THE FOREIGN BODY FROM THE EAR AND THERE WERE NO FURTHER MEDICAL INTERVENTION PERFORMED. IT WAS FURTHER REPORTED THAT THERE WERE NO FURTHER ISSUES WITH THE MIDDLE EAR OR THE EAR DRUM. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE AFFECTED EAR WAS THE LEFT EAR. PER THE ACCLARENT ENT CONSULTANT, THE FOREIGN BODY WAS REMOVED LIKELY WITH SOME FORCEPS. THE AERA BALLOON THAT WAS USED DURING THE PROCEDURE IS NOT AVAILABLE; IT WAS DISCARDED ON THE DAY OF THE INDEX PROCEDURE, (B)(6) 2023. THE ACCLARENT ENT CONS

  Patient problems: Discomfort; Itching Sensation

  MAUDE report 16873218 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A FEMALE PATIENT UNDERWENT BILATERAL EUSTACHIAN TUBE (ET) DILATION WITH THE ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / LOT# UNKNOWN) ON (B)(6) 2019. THE UNEVENTFUL PROCEDURE WAS COMPLETED WITHOUT ANY RESISTANCE OR BLEEDING. A SINGLE DILATION WAS COMPLETED BILATERALLY AT 12 ATM FOR 2 MINUTES. THERE WAS NO REPORT OF ANY ACCLARENT PRODUCT MALFUNCTION. THE PATIENT WAS DISCHARGED UNEVENTFULLY AS OUT-PATIENT AND WAS NOT GIVEN VALSALVA INSTRUCTION. POST-OPERATIVE DAY ONE, THE PATIENT REPORTED FEELING LIKE SHE WAS GETTING A COLD AND HAD SOME COUGHING. THE PATIENT CALLED FIRST POST-OPERATIVE DAY AND REPORTED RIGHT FACIAL SWELLING. THIS PROGRESSED TO INCLUDE MILD PAIN WITH SWALLOWING AND MILD DYSPHAGIA. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND HAD A COMPUTED TOMOGRAPHY (CT) SCAN OF THE FACE/NECK/CHEST. THERE WAS AIR PRESENT ON THE RIGHT SIDE OF THE FACE, LIMITED AIR IN THE RIGHT UPPER-NECK REGION AND A TRACE AMOUNT OF AIR IN THE CHEST, ALL CONSISTENT WITH SUBCUTANEOUS EMPHYSEMA. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND GIVEN SUPPORTIVE ARE AND PARENTAL ANTIBIOTICS; THE PATIENT EXPERIENCED NO DIS

  Patient problems: No Code Available

  MAUDE report 8516699 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2018, A FEMALE PATIENT UNDERWENT A BILATERAL EUSTACHIAN TUBE DILATION USING THE ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / LOT NUMBER NOT AVAILABLE) AND ANOTHER HYBRID PROCEDURE WITH NON-ACCLARENT DEVICES TO REMOVE A CYST FROM THE RIGHT SIDE OF THE NECK; THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA AFTER SHE WAS DISCHARGED. THE PATIENT REPORTED THAT SHE WAS GETTING ¿AIR IN THE NECK¿ AND WAS NOT ABLE TO POP HER EAR ON ONE SIDE. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND HAD A COMPUTED TOMOGRAPHY (CT) THAT REVEALED AIR IN THE RIGHT SIDE OF THE FACE, LIMITED AIR IN THE RIGHT UPPER NECK, AND TRACE OF AIR IN THE RIGHT CHEST. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ONE NIGHT ON HIGH-FLOW OXYGEN TO FACILITATE QUICK AIR ABSORPTION. THE PHYSICIAN REPORTED THAT THE PATIENT DID NOT HAVE ANY INFECTION BUT RECEIVED PROPHYLACTIC INTRAVENOUS (IV) ANTIBIOTICS WHILE SHE WAS IN THE HOSPITAL. THE PATIENT WAS TRANSITION AUGMENTIN AS AN OUTPATIENT. THE PHYSICIAN REPORTED THAT THE PATIENT RECOVERED WELL WITH ALL SYMPTOMS RESOLVED. THERE WAS NO PERMANENT INJURY SUFFERED. THE HYBRID PROCEDURE PERFORMED WAS DONE PRIOR TO T

  Patient problems: No Code Available; Swelling

  MAUDE report 7704854 ↗
• MalfunctionOct 10, 2017Bent; Material Rupture

  SURGEON WAS PREPARING THE ACCLARENT AERA EUSTACHIAN TUBE BALLOON CATHETER ON THE STERILE BACK TABLE TO BE SURE DEVICE WAS FUNCTIONAL. THE STAFF AND SURGEON NOTED THE BALLOON CATHETER WAS BENT AND THE BALLOON RUPTURED WHEN THE SURGEON BEGAN TO FILL THE BALLOON. COMPANY WAS NOTIFIED IMMEDIATELY AFTER THE CASE ABOUT THE DEFECT. MANUFACTURER RESPONSE: FOR EUSTACHIAN TUBE BALLOON DILATION DEVICE, ACCLARENT AERA (PER SITE REPORTER) MANUFACTURER WAS NOTIFIED AND SEND IN A REPLACEMENT DEVICE. REP WILL PICK UP NEXT TIME AT OUR FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935196 ↗