Arndt G44111Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002441118), received between Dec 11, 2018 and Oct 27, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Inflation Problem; Inflation Problem

  THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393084 ↗
• MalfunctionJan 8, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF AN ARNDT ENDOBRONCHIAL BLOCKER SET HAD INSUFFICIENT INFLATION. AFTER OPENING THE STERILE PACKAGE, THE BALLOON WAS CHECKED AND WAS FOUND TO NOT INFLATE PROPERLY. THEREFORE, THE DEVICE WAS NOT USED, AND ANOTHER PRODUCT WAS OBTAINED TO COMPLETE THE PROCEDURE. 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 18467256 ↗
• MalfunctionOct 27, 2022Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  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 15681972 ↗
• InjuryOct 21, 2022Inflation Problem; Inflation Problem

  IN ADDITIONAL INFORMATION RECEIVED ON 23NOV2022, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 15650647 ↗
• MalfunctionSep 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED A 4 YEAR OLD MALE PATIENT, WEIGHING 14 KGS, REQUIRED AN ARNDT ENDOBRONCHIAL BLOCKER SET. PRIOR TO PATIENT CONTACT, THE USER TESTED THE DEVICE FUNCTION AND FOUND THAT THE BALLOON INFLATED ONLY ON ONE SIDE. ANOTHER DEVICE, FROM THE SAME LOT, WAS ALSO TESTED AND RESULTED IN THE SAME ISSUE. THE BALLOON OF THE THIRD DEVICE, FROM A DIFFERENT UNKNOWN LOT, INFLATED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 15491601 ↗
• InjuryAug 13, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION PROVIDED ON 13AUG2019 STATES THAT "RESPIRATORY DOCTORS RETRIEVED REMNANTS OF BALLOON FROM PATIENTS LUNG," USING EBUS EQUIPMENT (BIOPSY FORCEPS). THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT WAS HAVING A ENDOBRONCHIAL ULTRASOUND OF THEIR LUNG.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8890277 ↗
• MalfunctionDec 11, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SEE H10.

  Patient problems: No Patient Involvement

  MAUDE report 8153517 ↗