Arndt G44114Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002441149), received between Nov 10, 2016 and Feb 17, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Material Rupture

  ADDITIONAL INFORMATION WAS PROVIDED ON 25FEB2026. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. IT IS UNKNOWN IF THE DEVICE WAS TEST INFLATED BEFORE INSERTION BECAUSE IT WAS AN EMERGENCY AND NO ONE IS ABLE TO REMEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367763 ↗
• MalfunctionJan 2, 2026Deflation Problem; Inflation Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945898 ↗
• MalfunctionDec 10, 2025Inflation Problem; Inflation Problem

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768193 ↗
• MalfunctionJul 22, 2025Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  THE DEVICE WAS RETURNED FOR INVESTIGATION ON 13NOV2025. DURING PRELIMINARY DEVICE EVALUATION, IT WAS DETERMINED THE BALLOON OF THE ARNDT ENDOBRONCHIAL BLOCKER CATHETER WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566493 ↗
• MalfunctionJun 24, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED. THE DEVICE WAS REQUIRED FOR A CRYOPULMONARY BIOPSY. THE BALLOON WAS TEST INFLATED WITH 4 ML WHEN THE LEAK WAS DISCOVERED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER, NEW DEVICE AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322595 ↗
• MalfunctionJun 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BLOCKER BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET WOULD NOT RETAIN AIR. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179660 ↗
• MalfunctionMar 26, 2025Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE BALLOON INCLUDED IN THE ARNDT ENDOBRONCHIAL BLOCKER SET FAILED TO INFLATE AND LEAKED DURING AN AIRWAY CRYOBIOPSY PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE BALLOON WAS INFLATED WITH 5ML OF AIR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701082 ↗
• MalfunctionMar 20, 2025Material Rupture; Gas/Air Leak; Material Rupture; Gas/Air Leak

  IT WAS REPORTED THAT AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS REQUIRED FOR A FROZEN LUNG BIOPSY PROCEDURE. DURING DEVICE TESTING, PRIOR TO PATIENT CONTACT, THE BALLOON WAS FILLED WITH 10ML OF AIR AND LEAKAGE WAS DISCOVERED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654175 ↗
• MalfunctionNov 10, 2016Inflation Problem; Inflation Problem

  CUSTOMER REPORTED THAT A PATIENT UNDERWENT A PLANNED ESOPHAGECTOMY FOR AN ESOPHAGEAL REPAIR. AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS USED TO SELECTIVELY BLOCK ONE LUNG DURING THE PROCEDURE. THE DEVICE WAS SET WITHIN THE MAIN BRONCHUS OF THE RIGHT LUNG AND REPORTEDLY FAILED TO INFLATE EVENLY. THE EVENT ALLEGEDLY CAUSED AN IMPRESSION / INDENTATION OF THE LUNG TISSUE ( BRONCHUS) WITH LOCALIZED CAPILLARY BLEEDING. NO INTERVENTION WAS NEEDED TO ALLEVIATE THE IMPRESSION OR TO CONTROL THE CAPILLARY OOZE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 6092502 ↗