Arndt G26907Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002269071), received between Mar 10, 2017 and Nov 10, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Air Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 10, 2017Break; Component Missing; Break; Component Missing

  PRIOR TO THE OPENING OF THE PACKAGE, IT WAS OBSERVED THAT THE TIP OF THE SYRINGE IN THE ARNDT ENDOBRONCHIAL BLOCKER SET WAS "BROKEN AND MISSING" (SIC). THE PRODUCT ISSUE WAS DISCOVERED PRIOR TO USE; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT MALFUNCTION. THE PRODUCT WAS RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Patient Involvement

  MAUDE report 7017955 ↗
• MalfunctionOct 24, 2017Air Leak; Decrease in Pressure; Air Leak; Decrease in Pressure

  THE CUSTOMER REPORTED THAT THE BALLOON PORTION OF AN ARNDT ENDOBRONCHIAL BLOCKER SET WOULD NOT REMAIN INFLATED WHEN USED IN THE PATIENT. THE PATIENT PRESENTED WITH BLEEDING IN THE LOWER RIGHT LUNG, SO THE OPERATOR ELECTED TO PLACE THE BLOCKER IN THE RIGHT MAIN STEM. THE BALLOON WAS THEN INFLATED TO BETWEEN 5 AND 6 CC'S OF AIR. THE ADAPTOR WAS THEN SCREWED DOWN, AND RENDERED IMMOVABLE. HOWEVER, UPON THE RESCOPING OF THE PATIENT THE FOLLOWING DAY, THE BALLOON WAS OBSERVED TO BE COMPLETELY DEFLATED. THE BALLOON WAS THEN RE-INFLATED AND SCREWED INTO PLACE ONCE MORE - THIS TIME WITH 7 CC'S OF AIR; BUT, 8 HOURS LATER, THE BALLOON WAS AGAIN FOUND TO BE DEFLATED. THE BLEEDING FINALLY CEASED FOLLOWING NUMEROUS BRONCHOSCOPIES USING COLD SALINE FLUSHES. THE PATIENT HAD EMPHYSEMA, AND WAS ON BLOOD THINNERS. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6972720 ↗
• InjuryMar 10, 2017Deflation Problem; Deflation Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A (B)(6) PATIENT UNDERWENT A THORACOSCOPY FOR A CHEST WALL TUMOR BIOPSY. AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS EMPLOYED TO FOR ANESTHESIA MANAGEMENT DURING THE PROCEDURE. THE DEVICE WAS TESTED FOR LEAKS PRIOR TO USE THEN INSERTED INTO ONE LUNG AND INFLATED. THE CONDITIONS, MANIPULATIONS AND CIRCUMSTANCES SURROUNDING THE INITIAL TESTING OF THE DEVICE ARE NOT KNOWN. THE BALLOON DEFLATED AT AN UNSPECIFIED TIME DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND A NEW DEVICE USED. THE EVENT RESULTED IN AN EXTENSION OF THE PROCEDURE AND ANESTHESIA TIME. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER PATIENT OR DEVICE EVENTS WERE REPORTED. POST REMOVAL EXAMINATION OF THE DEVICE BY THE USER REVEALED A LEAK AT THE JUNCTION OF THE PILOT BALLOON ASSEMBLY TUBE AND THE BLUE WING SHAPED COMPONENT. THE USER COMMENTED THAT IT WAS DIFFICULT TO ASSESS THE LEAKAGE BECAUSE THE AMOUNT OF LEAKAGE WAS DEPENDENT UPON THE ORIENTATION OF THE DEVICE; ONE ORIENTATION ALLOWED FOR A SLOW LEAK WHICH MAINTAINED BALLOON INFLATION AND ANOTHER ORIENTATION ALLOWED FOR A RAPID LEAK AND SUBSEQUENT DEFLATION OF THE BALLOON. THE INSTRUCTIONS FOR USE (IFU) STATE IN THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6396866 ↗