Arndt G13280Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002132801), received between Nov 19, 2020 and Jun 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED A PATIENT REQUIRED A ARNDT ENDOBRONCHIAL BLOCKER SET FOR AN UNKNOWN PROCEDURE. IT WAS NOTED THAT WHEN THE USER INFLATED THE BALLOON TO VERIFY THE DEVICE FUNCTION PRIOR TO PATIENT CONTACT, THE BALLOON INFLATED IN A DEFORMED SHAPE. THEY STATED ONLY "ONE SIDE/HALF OF THE BALLOON COULD BE INFLATED." ANOTHER SIMILAR DEVICE WAS USED INSTEAD 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 14737023 ↗
• MalfunctionNov 19, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF A ARNDT ENDOBRONCHIAL BLOCKER SET WAS NOT ABLE TO INFLATE PROPERLY. THE USER ATTEMPTED TO INFLATE THE BALLOON PRIOR TO PATIENT USE, BUT FOUND THAT ONLY ONE SIDE WAS ABLE TO INFLATE. NO PATIENT CONTACT WAS MADE. ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10870027 ↗