Shiley 125037 (UDI 40884522008748)Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 40884522008748), received between Jun 23, 2017 and Sep 15, 2026 — classified as 1 death, 20 injuries, 188 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (103 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 25 most recent of 209 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777867 ↗
• MalfunctionAug 8, 2026Use of Device Problem

  It was reported that the bronco catheter's cuff failed to inflate at a hospital prior to use. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184626 ↗
• MalfunctionJul 31, 2026Use of Device Problem

  Patient problems: Insufficient Information

  MAUDE report 50098072 ↗
• MalfunctionJul 28, 2026

  It was reported that during use, the endotracheal tube's cuff had an inflation or deflation issue. Patient outcome was asked but unknown.

  Patient problems: Insufficient Information

  MAUDE report 50055294 ↗
• MalfunctionJun 23, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER INDUCTION OF ANESTHESIA, THE ENDOTRACHEAL INTUBATION WAS SUCCESSFULLY COMPLETED ON THE FIRST ATTEMPT. BILATERAL LUNG VENTILATION WITH THE WHITE CUFF WAS NORMAL. THE PATIENT WAS THEN REPOSITIONED FROM THE SUPINE POSITION TO THE LEFT LATERAL POSITION. AFTER SUCCESSFUL POSITIONING WITH A FIBEROPTIC BRONCHOSCOPE, SINGLE-LUNG VENTILATION WAS INITIATED WITH THE BLUE CUFF INFLATED, BUT AIR LEAKAGE WAS DETECTED. THE DEPTH OF THE TUBE WAS ADJUSTED AGAIN, BUT LEAKAGE PERSISTED. THE PATIENT WAS THEN RETURNED TO THE SUPINE POSITION, AND THE TUBE WAS REMOVED AND INSPECTED, CONFIRMING AIR LEAKAGE FROM THE TUBE. ANOTHER TUBE WAS INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unintended Extubation

  MAUDE report 25590570 ↗
• MalfunctionJun 9, 2026Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE CUFF OF THE BRONCO CATHETER HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445670 ↗
• MalfunctionJun 3, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE DOUBLE LUMEN TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25378131 ↗
• MalfunctionMar 23, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THE DOUBLE LUMEN TUBE'S BRONCHIAL CUFF HAD AN AIR LEAK, AS SHOWN IN THE IMAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664773 ↗
• MalfunctionMar 12, 2026Connection Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE COVER OF THE CONNECTOR OF THE BRONCO CATHETER DID NOT FIT PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576805 ↗
• MalfunctionMar 6, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, THE DOUBLE LUMEN TUBE'S CUFF HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532381 ↗
• MalfunctionFeb 20, 2026Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT PRIOR TO USE, THE PILOT BALLOON WAS LOOSE AND THE AND HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399957 ↗
• MalfunctionFeb 19, 2026Use of Device Problem

  IT WAS REPORTED THAT AIR LEAKAGE OCCURRED IN THE WHITE CUFF OF THE DUAL-LUMEN TUBE AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395391 ↗
• MalfunctionFeb 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER RIPPED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24300617 ↗
• MalfunctionFeb 5, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE DOUBLE-LUMEN BRONCHIAL TUBE'S CUFF WAS FOUND TO HAVE A SEVERE AIR LEAK, MAKING BILATERAL LUNG VENTILATION IMPOSSIBLE. FORTUNATELY, VENTILATION ON THE HEALTHY SIDE WAS ADEQUATE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267403 ↗
• MalfunctionJan 15, 2026Use of Device Problem

  IT WAS REPORTED THAT THE FIRST BRONCO CATHETER'S CUFF DID NOT EXPAND DURING USE AND WAS REPLACED. THE SECOND TUBE DID NOT CONTRACT AND WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24084784 ↗
• MalfunctionJan 15, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE FIRST BRONCO CATHETER'S CUFF DID NOT EXPAND DURING USE AND WAS REPLACED. THE SECOND TUBE DID NOT CONTRACT AND WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24084775 ↗
• MalfunctionJan 12, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING USE, THE CUFF OF THE BRONCO CATHETER HAD INFLATION AND DEFLATION ISSUE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 24035609 ↗
• MalfunctionJan 6, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, THE BRONCO CATHETER'S CAP WAS FOUND DAMAGED AND COULD NOT BE FITTED INTO THE TUBE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977135 ↗
• MalfunctionDec 29, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT EVEN WHEN THE SLIP JOINT WAS PUSHED IN BEFORE USE, THE SLIP JOINT DETACHED FROM THE ENDOTRACHEAL TUBE JUST BY LIGHTLY TOUCHING THE ANESTHESIA CIRCUIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23910478 ↗
• MalfunctionDec 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN TESTED WITH A SYRINGE, THE AIR DID NOT MOVE QUICKLY DURING THE INFLATE/DEFLATE TEST OF THE BRONCO CATHETER'S CUFF. THERE WAS NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853561 ↗
• MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785368 ↗
• MalfunctionDec 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767224 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, BOTH DOUBLE LUMEN BRONCHIAL TUBE'S CUFF HAD LEAKAGE AFTER INFLATED TO A PRESSURE OF 25 CMH2O AND IMMERSED IN NORMAL SALINE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570194 ↗
• MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OFF THE BRONCO CATHETER HAD AN AIR LEAK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915806 ↗
• MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THREE DOUBLE-LUMEN AND AN ENDOTRACHEAL TUBE'S CUFF EACH HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815923 ↗