INSPIRA AIR BC1640ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031147744), received between Dec 19, 2017 and Oct 15, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deflation 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Material Rupture; Material Separation; Patient Device Interaction Problem; Material Rupture; Material Separation; Patient Device Interaction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY AIRWAY PROCEDURE TARGETING AN UPPER-AIRWAY STENOSIS (AIRWAY STENOSIS ABOVE THE TRACHEA), THE 16MM X 40MM INSPIRA AIR BALLOON DILATION SYSTEM (BC1640A / (B)(4) RUPTURED AND A PIECE OF IT ENDED UP IN THE RIGHT BRONCHUS. THE PHYSICIAN DESCRIBED THE EVENT AS FOLLOWS: ¿HE HAD THE BALLOON INFLATED AT 8 ATM FOR ONE MINUTE WHEN HE HEARD A LOUD POP AND LOST PRESSURE.¿ THE PHYSICIAN REPORTED THAT DURING THE ATTEMPT TO REMOVE THE BALLOON, THE BALLOON SNAPPED OFF THE SHAFT. ENDOSCOPIC VISUALIZATION SHOWED PART OF THE BALLOON HAD MIGRATED TO THE RIGHT MAIN BRONCHI. THE BALLOON WAS RETRIEVED USING THE ENDOSCOPE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THIS WAS NOT A PEDIATRIC CASE. THE MALE PATIENT HAS A SEVERE GRADE 3 STENOSIS; HE HAS UNDERGONE THREE PRIOR SURGERIES FOR STENOSIS. THE PATIENT WAS REPORTED TO BE ¿VERY ILL PRIOR TO THE CASE BUT PATIENT IS PERFECTLY GOOD FOLLOWING THE BALLOON RUPTURE. [THE RUPTURE] DID NOT CAUSE THE PATIENT ADDITIONAL HOSPITAL TIME.¿ THERE WAS NO TRAUMA OR INJURY TO THE PATIENT¿S STENOSED AIRWAY

  Patient problems: Airway Obstruction

  MAUDE report 20453210 ↗
• InjuryJul 18, 2022Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN AIRWAY DILATION PROCEDURE, WHEN THE 16MM X 40MM INSPIRA AIR BALLOON DILATION SYSTEM (BC1640A / LOT# UNKNOWN) WAS INFLATED INSIDE THE PATIENT¿S AIRWAY, THE BALLOON SUDDENLY DETACHED FROM THE SHEATH AND WAS STUCK INSIDE OF THE PATIENT¿S TRACHEA. AT THE TIME OF THE COMPLAINT INITIATION, THE STATUS OF THE PATIENT IS NOT KNOWN. ON (B)(6) 2022, PER A CONVERSATION BETWEEN THE ACCLARENT ENT CONSULTANT (ENTC) AND THE ACCLARENT PRINCIPAL QUALITY ENGINEER, THE ACCLARENT ENTC CONFIRMED THAT THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON AND THERE WAS NO SIGNIFICANT HARM AS A RESULT OF THE DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048736 ↗
• InjuryOct 12, 2020Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN AIRWAY DILATION PROCEDURE ON THE (B)(6)-YEAR-OLD MALE PATIENT, THE PHYSICIAN WAS ABLE TO DILATE THE AIRWAY USING THE 14MM X 40MM INSPIRA AIR BALLOON DILATION SYSTEM WITHOUT ANY ISSUE. THEN THE PHYSICIAN ASKED FOR THE 16MM X 40MM INSPIRA AIR BALLOON DILATION SYSTEM (BC1640A / 200210-B-PC). UPON INFLATING, THE 16MM X 40MM BALLOON RUPTURED ALONG THE SHAFT OF THE DEVICE. THE BALLOON WAS INFLATED PER THE INSTRUCTIONS FOR USE (IFU) WITH 16CC OF SALINE USING THE ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375229) TO 8 ATM. AFTER FULLY DEFLATING THE DEVICE, THE BALLOON CAME APART IN TWO PIECES. THE REMAINING PART WAS REMOVED USING A PAIR OF STAINLESS-STEEL REUSABLE GRASPERS. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THERE WAS NO ISSUE WITH THE PATIENT¿S ANATOMY THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEVICE ISSUE. IT WAS REPORTED THAT THE BID30 DEVICE WAS ALSO USED TO INFLATE THE 14MMX 40MM INSPIRA BALLOON WITHOUT ANY ISSUE. THE PROCEDURE WAS CONSIDERED SUCCESSFULLY COMPLETED AS THE 16MM X 40MM INSPIRA AIR BALLOON PROVIDED ADEQUATE DILATION BEFORE IT RUPTURED AND NOTHING ADDITIONAL WAS REQUIRED. THE PATIENT UNDERWENT ROUTINE POST

  Patient problems: No Code Available

  MAUDE report 10667102 ↗
• MalfunctionFeb 6, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCLARENT WAS INFORMED ON (B)(4) 2018, OF AN EVENT INVOLVING AN INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM (LOT# UNAVAILABLE), THAT WAS USED DURING AN AIRWAY DILATION PROCEDURE THAT TOOK PLACE IN THE PREVIOUS WEEK. THE EXACT DATE OF THE PROCEDURE IS NOT KNOWN. PER THE DISCUSSION ON THE PHONE FROM THE ACCLARENT MEDICAL DIRECTOR WITH THE PHYSICIAN WHO PERFORMED THE PROCEDURE, THE PROCEDURE WAS TO TREAT A CHALLENGING STENOSIS EXTENDING FROM THE SUBGLOTTIS TO THE UPPER TRACHEA ON A PATIENT THAT IS REPORTED TO BE OBESE AND HAD UNDERWENT SEVERAL AIRWAY DILATION PROCEDURES IN THE PAST. INITIALLY IN THE PROCEDURE, THE 14MM INSPIRA AIR BALLOON WAS USED BUT THE BALLOON BURST; THE PHYSICIAN REPORTED THAT THE BURST WAS ATTRIBUTED TO THE VERY FIRM AND LONG NATURE OF THE STENOSIS. THE PHYSICIAN REPORTED THAT BALLOONS HAVE BURST TREATING THIS PATIENT IN THE PAST DUE TO THE CHALLENGING NATURE OF THE STENOSIS. A 16MM INSPIRA AIR BALLOON WAS USED AND THE BALLOON WAS REPORTED TO HAVE EXPERIENCE WATERMELON SEEDING-LIKE PHENOMENON WHICH REQUIRED SOME PROXIMAL PULL TO CONTROL THE POSITIONING OF THE BALLOON. THE BALLOON SUDDENLY SEPARATED FROM THE SHAFT BUT WAS STILL PARTIALLY INFLATED DESPITE BEING SE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245015 ↗
• MalfunctionFeb 5, 2018Detachment Of Device Component; Deflation Problem; Detachment Of Device Component; Deflation Problem

  ACCLARENT WAS INFORMED ON 01/11/2018, OF AN EVENT INVOLVING AN INSPIRA AIR BALLOON DILATION SYSTEM, 16 X 40 MM (LOT# UNAVAILABLE), THAT WAS USED DURING AN AIRWAY DILATION PROCEDURE THAT TOOK PLACE APPROXIMATELY 3 TO 4 MONTHS BEFORE THAT WAS THOUGHT TO HAVE BEEN REPORTED TO ACCLARENT. PER THE DISCUSSION ON THE PHONE FROM THE ACCLARENT MEDICAL DIRECTOR WITH THE PHYSICIAN WHO PERFORMED THE PROCEDURE, THE PROCEDURE WAS TO TREAT A SUBGLOTTIC STENOSIS USING A 14 OR 16 MM INSPIRA AIR BALLOON. THE PHYSICIAN WAS NOT ABLE TO RECALL THE EXACT SIZE OF THE BALLOON AND THE BALLOON HAS SINCE BEEN DISCARDED. THE EVENT REPORTED WAS THE INSPIRA AIR BALLOON APPEARED TO HAVE PARTIALLY SEPARATED FROM THE SHAFT OF THE CATHETER AND THERE WAS DIFFICULTY IN DEFLATING THE BALLOON. THE BALLOON DEFLATION WAS ACHIEVED BY BEING PUNCTURED IN THE AIRWAY USING A LONG-HANDLED KNIFE. THE BALLOON WAS CAREFULLY RETRIEVED FROM THE AIRWAY. THE PATIENT WAS REPORTED TO HAVE ACHIEVED SOME DILATION AND DID NOT REQUIRE ANY ADDITIONAL SURGICAL INTERVENTION. THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7241443 ↗
• MalfunctionDec 19, 2017Deflation Problem; Deflation Problem

  ACCLARENT WAS INFORMED ON (B)(6) 2017, OF AN EVENT THAT OCCURRED ON (B)(6) 2017, INVOLVING AN INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM (LOT#: 160518A-PC). IT WAS REPORTED THAT DURING THE BRONCHIAL DILATION PROCEDURE, THE INSPIRA BALLOON WOULD NOT DEFLATE. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7132354 ↗