ACCLARENT BALLOON INFLATION DEVICE BID30Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031063570), received between Mar 22, 2024 and May 15, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (15 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, WHEN THE PACKAGING OF AN ACCLARENT BALLOON INFLATION DEVICE (BID30, LOT UNKNOWN) WAS OPENED, IT HAD A RESIDUE ON IT (AS SEEN IN THE PHOTOS). NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029199 ↗
• MalfunctionDec 26, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID BALLOON SINUPLASTY PROCEDURE (BSP), WHEN THE ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375267) WAS REMOVED FROM ITS PACKAGING, A WHITE SUBSTANCE WAS NOTICED ON THE HANDLE OF THE DEVICE. THE REPORTER STATED THAT ¿THE WHITE SUBSTANCE MAY HAVE BEEN PAPER FROM THE LABEL RUBBING OFF.¿ THE ACCLARENT BALLOON INFLATION DEVICE WAS REPLACED WITH ANOTHER FROM THE SAME LOT (96375267), BUT THE SAME WHITE SUBSTANCE WAS NOTICED ON THE HANDLE. THE DEVICE WAS REPLACED A THIRD TIME, AND THE THIRD DEVICE HAD NO WHITE SUBSTANCE ON IT. THE PROCEDURE WAS RESUMED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21022653 ↗
• MalfunctionDec 26, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID BALLOON SINUPLASTY PROCEDURE (BSP), WHEN THE ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375267) WAS REMOVED FROM ITS PACKAGING, A WHITE SUBSTANCE WAS NOTICED ON THE HANDLE OF THE DEVICE. THE REPORTER STATED THAT ¿THE WHITE SUBSTANCE MAY HAVE BEEN PAPER FROM THE LABEL RUBBING OFF.¿ THE ACCLARENT BALLOON INFLATION DEVICE WAS REPLACED WITH ANOTHER FROM THE SAME LOT (96375267), BUT THE SAME WHITE SUBSTANCE WAS NOTICED ON THE HANDLE. THE DEVICE WAS REPLACED A THIRD TIME, AND THE THIRD DEVICE HAD NO WHITE SUBSTANCE ON IT. THE PROCEDURE WAS RESUMED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21022652 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229031 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229026 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228998 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228980 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228970 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228954 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228949 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228938 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, (B)(6)) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228926 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES(B)(6) (SEID, (B)(6) ) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228896 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, (B)(6)) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6)2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228890 ↗
• MalfunctionMay 2, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, INSIDE THE STERILE PACKAGE OF 15 ACCLARENT SE INFLATION DEVICES (SEID, 96375262) WHITE RESIDUE WAS PRESENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-APR-2025 FURTHER CLARIFIED THAT THE ¿WHITE RESIDUE¿ IS BEST DESCRIBED AS ¿ALMOST MOISTURE IN THE PACKAGE¿. THERE WERE NO PATIENT CONSEQUENCES AS THE DEVICES WERE NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228844 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A BALLOON SINUPLASTY (BSP) PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY THAT RESULTED IN HER SUFFERING A CATASTROPHIC STROKE. THE REPORTED DEVICES USED DURING THE PROCEDURE WERE: A RELIEVE TRACT BALLOON (RT1640A / 211202A-PC), TWO 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN), ONE FROM LOT 220419A-PC AND ONE FROM LOT 220504A-PC, A DISPOSABLE TRUDI PROBE 0-DEGREE, 5IN (TDP0005 / 210201B-PC), AN ACCLARENT BALLOON INFLATION DEVICE (BID30 / 96375250), AND A TRUDI NAV CABLE (TDNC001 / 211206C-PC) AND THE TRUDI NAVIGATION SYSTEM. IT IS REPORTED THAT THE PATIENT BELIEVED THAT THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND ITS COMPONENT PARTS, INCLUDING ANY AI (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE, AND THAT AS A RESULT, THE PATIENT¿S CAROTID ARTERY WAS INJURED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18962842 ↗