Arndt G44120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002441200), received between Apr 9, 2019 and Jan 14, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2026Material Rupture; Detachment of Device or Device Component

  IN ADDITIONAL INFORMATION PROVIDED 16JAN2026, THE PHYSICIANS STATED THE ISSUE IS RELATED TO A USAGE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069397 ↗
• MalfunctionMay 16, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED DURING AN INFLATION TEST PRIOR TO AN UNKNOWN PROCEDURE. TO COMPLETE THE PROCEDURE, THE OPERATOR PERFORMED ONE LUNG VENTILATION WITH ANOTHER ENDOBRONCHIAL BLOCKER FROM ANOTHER MANUFACTURER. THE PRODUCT DID NOT MAKE CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT DEMOGRAPHICS OR PRE-EXISTING CONDITIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8617112 ↗
• MalfunctionApr 9, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495983 ↗