Arndt G44109Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002441095), received between Mar 24, 2017 and May 15, 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Inflation Problem

  IT WAS REPORTED THAT AN ARNDT ENDOBRONCHIAL BLOCKER DID NOT INFLATE PRIOR TO USE IN AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. AT THIS TIME, NO HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

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

  MAUDE report 25183382 ↗
• MalfunctionDec 1, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 09DEC2025, IT WAS REPORTED THAT A 1.5ML VOLUME WAS USED TO INFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687548 ↗
• MalfunctionNov 17, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  COOK WAS NOTIFIED THAT DURING PREOPERATIVE PREPARATION; THE BALLOON WAS TEST INFLATED AND WAS FOUND TO INFLATE SYMMETRICALLY AND LEAK. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE DEVICE WAS RETURNED ON (B)(6) 2025 AND A PINHOLE WAS FOUND IN THE SEAM OF THE BALLOON. THE BALLOON WAS INFLATED WITH 2 CC OF AIR, BUT WOULD NOT STAY INFLATED. 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 23576088 ↗
• MalfunctionApr 22, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON INCLUDED IN THE ARNDT ENDOBRONCHIAL BLOCKER SET WAS UNABLE TO BE INFLATED DURING A LUNG ISOLATION FOR A LUNG BIOPSY PROCEDURE. PER THE CUSTOMER, THERE SEEMED TO BE A HOLE IN THE BALLOON. IT WAS NOTED THAT MINIMAL PRESSURE WAS APPLIED DURING BALLOON INFLATION USING THE PROVIDED SYRINGE PRIOR TO PATIENT USE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT, AND AN UNSPECIFIED DOUBLE-LUMEN TUBE WAS UTILIZED TO SUCCESSFULLY 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 21884610 ↗
• MalfunctionMar 25, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED DURING TESTING, PRIOR TO PATIENT CONTACT. 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 21691679 ↗
• MalfunctionMar 25, 2025Material Rupture; Gas/Air Leak; Material Rupture; Gas/Air Leak

  IT WAS REPORTED THAT THE BALLOON FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED DURING TESTING, PRIOR TO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH 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 21691611 ↗
• MalfunctionFeb 26, 2025Deflation Problem; Deflation 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 21470300 ↗
• MalfunctionApr 4, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE INTERNATIONAL CUSTOMER REPORTED PRIOR TO PATIENT CONTACT THE ARNDT ENDOBRONCHIAL BLOCKER SET WAS NOTED TO HAVE A FOREIGN OBJECT IN THE STERILE PACKAGING. THE PRODUCT AND PACKAGING HAS BEEN RECEIVED FOR EVALUATION AND INVESTIGATION; HOWEVER, THE INVESTIGATION IS STILL IN PROGRESS AT THE TIME OF THIS REPORT. .

  Patient problems: No Patient Involvement

  MAUDE report 7397980 ↗
• MalfunctionMar 24, 2017Inflation Problem; Inflation Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A VIDEO ASSISTED THORASCOPIC SURGERY (VATS) PROCEDURE FOR AN UNSPECIFIED INDICATION. AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS EMPLOYED TO SELECTIVELY ISOLATE AN UNSPECIFIED PULMONARY LOBE FOR VENTILATION. THE CUSTOMER STATED THAT THE DEVICE HAD A MAJOR LEAKAGE WHILE ATTEMPTING TO VENTILATE THE PATIENT. THE DEVICE COULD NOT BE "TIGHTENED;" THE LEAKAGE COULD NOT BE CONTROLLED OR STOPPED. THE INSTRUCTIONS FOR USE INDICATE THAT AIR LEAKAGE CAN BE CONTROLLED BY SCREWING DOWN THE CAP ON THE BLOCKER PORT. IT IS NOT KNOWN WHAT ACTIONS WERE TAKEN TO ADDRESS OR COMPLETE THE PROCEDURE, HOWEVER A NURSE REPORTED THAT THE DEVICE WAS NOT USED ONCE THE LEAK WAS NOTED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EXAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6432150 ↗