Shiley 125039 (UDI 40884522008755)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 40884522008755), received between Aug 8, 2017 and Apr 29, 2026 — classified as 7 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER HAD A CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029506 ↗
• MalfunctionApr 28, 2026Use of Device Problem

  IT WAS REPORTED THAT THE BRONCO CATHETER HAD A CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023485 ↗
• MalfunctionFeb 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE DOUBLE LUMEN ENDOTRACHEAL TUBE'S TRACHEAL CUFF HAD AN AIR LEAKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292560 ↗
• MalfunctionJan 27, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING USE OF A DOUBLE-LUMEN TUBE, A FOREIGN OBJECT (BLUE FIBER) WAS DETECTED IN THE BRONCHIAL LUMEN AFTER INTUBATION AND DURING FIBEROPTIC POSITION CONTROL. AN ATTEMPT WAS MADE TO RETRIEVE THE FIBER USING SUCTION, BUT IT COULD NOT BE DETECTED IN THE SUCTION SYSTEM, THE TUBE, OR THE PATIENT AFTER THE RETRIEVAL ATTEMPT. A FIBEROPTIC INSPECTION OF THE PLASTIC COMPONENTS AND TUBES SHOWED NO EVIDENCE OF THE FOREIGN OBJECT, AND A VISUAL INSPECTION REVEALED THAT BOTH CUFFS APPEARED TO BE INTACT AND LEAK-FREE. THE DOUBLE-LUMEN TUBE WAS REPLACED BEFORE THE SURGICAL PROCEDURE BEGAN THROUGH A TROUBLE-FREE REINTUBATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 24193133 ↗
• MalfunctionJan 8, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE THREE BRONCO CATHETERS HAD SLOW LEAKS DETECTED IN THE TRACHEAL CUFFS DURING PATIENT INTUBATION ONCE THE TUBE WAS IN SITU, IN A HOSPITAL SETTING. THE TUBES WERE REPLACED EVERY TIME IT FAILED AND LASTLY, A 41L TUBE WAS USED, AND SUCCESSFUL INTUBATION WAS ACHIEVED WITH NO FURTHER CUFF ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 24012520 ↗
• MalfunctionJan 8, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE THREE BRONCO CATHETERS HAD SLOW LEAKS DETECTED IN THE TRACHEAL CUFFS DURING PATIENT INTUBATION ONCE THE TUBE WAS IN SITU, IN A HOSPITAL SETTING. THE TUBES WERE REPLACED EVERY TIME IT FAILED AND LASTLY, A 41L TUBE WAS USED, AND SUCCESSFUL INTUBATION WAS ACHIEVED WITH NO FURTHER CUFF ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 24012515 ↗
• MalfunctionJan 8, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE THREE BRONCO CATHETERS HAD SLOW LEAKS DETECTED IN THE TRACHEAL CUFFS DURING PATIENT INTUBATION ONCE THE TUBE WAS IN SITU, IN A HOSPITAL SETTING. THE TUBES WERE REPLACED EVERY TIME IT FAILED AND LASTLY, A 41L TUBE WAS USED, AND SUCCESSFUL INTUBATION WAS ACHIEVED WITH NO FURTHER CUFF ISSUES.

  Patient problems: Unintended Extubation

  MAUDE report 24012487 ↗
• MalfunctionNov 3, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO USAGE, THE DOUBLE LUMEN TUBE'S TIP HAD COLLOID DEFORMATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450570 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING TESTING OF THE TWO BRONCO CATHETERS, A CUFF LEAK WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089918 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING TESTING OF THE TWO BRONCO CATHETERS, A CUFF LEAK WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089900 ↗
• MalfunctionSep 12, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USAGE, IT WAS FOUND THAT THE DOUBLE LUMEN TUBE HAD A DEFECTIVE CAP AND DIFFICULT TO SEAL, AS SHOWN IN THE ATTACHED IMAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038357 ↗
• MalfunctionMar 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 39FR BRONCO CATHETER'S CUFF WAS TESTED PRIOR TO USE AT THE HOSPITAL, BUT NO PRESSURE INCREASE WAS OBSERVED, INDICATING A MALFUNCTION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727297 ↗
• MalfunctionJan 15, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE BRONCO CATHETER'S TUBE BODY WAS BENT. THE ISSUE OCCURRED IN A HOSPITAL SETTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164647 ↗
• MalfunctionDec 10, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WAS A BLUE PLASTIC SEEN IN THE BRONCHIAL LUMEN FOLLOWING INTUBATION. IT HAD TO BE REMOVED AND REPLACED CAUSING ADDITIONAL AIRWAY INSTRUMENTATION.

  Patient problems: Unintended Extubation

  MAUDE report 20888928 ↗
• InjuryDec 2, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A BRONCO CATHETER, A PATIENT REQUIRED REMOVAL OF A CORRECTLY SITED DOUBLE LUMEN TUBE AND REINTUBATION DUE TO INCREASED INSTRUMENTATION, LIP LACERATION AND SORE THROAT AT THE AIRWAY. A PIECE OF BLUE MATERIAL WAS EVIDENT IN THE BRONCHIAL LUMEN OF THE DOUBLE LUMEN TUBE FOLLOWING A DIFFICULT INTUBATION, WHICH RESULTED IN NO FURTHER VENTILATION THROUGH THE LUMEN. THERE WAS A CONCERN THAT AN UNRECOGNIZED FOREIGN BODY COULD BE INTRODUCED INTO THE AIRWAY OR LUNG WITH VENTILATION. THE TUBE WAS SUBSEQUENTLY REMOVED AND REPLACED.

  Patient problems: Adult Respiratory Distress Syndrome; Foreign Body In Patient; Laceration(s); Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 20818226 ↗
• MalfunctionJun 21, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFFS DID NOT EXPAND AND DEFLATE NORMALLY DURING THE PRE-USAGE INSPECTION. WHEN AIR WAS INJECTED INTO THE WHITE CUFF, BOTH THE WHITE AND BLUE CUFFS INFLATED. THERE WERE NO CHANGES EVEN AFTER AIR INJECTION INTO THE BLUE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586693 ↗
• MalfunctionJul 7, 2022Gas/Air Leak; Manufacturing, Packaging or Shipping Problem; Gas/Air Leak; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING THE OPENING TEST, IT WAS FOUND THAT THE CUFF LEAKED AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946010 ↗
• MalfunctionMar 18, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE DEVICE HAD A LEAK WHEN INFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13815444 ↗
• MalfunctionMar 8, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING PLACING THE TUBE ON THE PATIENT'S LEFT SIDED BRONCHUS, THE PEDIATRIC BRONCHOSCOPE COULD EASILY PASS VIA BRONCHIAL LUMEN BUT WHEN THE DEVICE WAS INSERTED, IT COULD NOT ADVANCE IN THE TRACHEAL LUMEN AND MORE EFFORT NEEDED TO APPLIED. THE DEVICE WAS REPLACED WITH A SINGLE LUMEN TUBE THEN A FRENCH 41 DOUBLE LUMEN TUBE VIA BOUGIE IN ORDER TO HAVE A DOUBLE LUMEN TUBE THAT WOULD ALLOW FOR EASE OF PASSAGE OF PEDIATRIC BRONCHOSCOPE. THE PATIENT HAS PARTIAL VIEW OF GLOTTIS. THE FAILURE RESULTED TO DELAY OF TREATMENT. THE PHYSICIAN TRIED THE SCOPE TO ANOTHER NEW FR 39 TUBE TO TEST IF IT ALSO HAD SAME ISSUE AND FOUND THAT THERE WAS ALSO RESISTANCE IN TRACHEAL LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13700911 ↗
• MalfunctionMar 8, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING PLACING THE TUBE ON THE PATIENT'S LEFT SIDED BRONCHUS, THE PEDIATRIC BRONCHOSCOPE COULD EASILY PASS VIA BRONCHIAL LUMEN BUT WHEN THE DEVICE WAS INSERTED, IT COULD NOT ADVANCE IN THE TRACHEAL LUMEN AND MORE EFFORT NEEDED TO APPLIED. THE DEVICE WAS REPLACED WITH A SINGLE LUMEN TUBE THEN A FRENCH 41 DOUBLE LUMEN TUBE VIA BOUGIE IN ORDER TO HAVE A DOUBLE LUMEN TUBE THAT WOULD ALLOW FOR EASE OF PASSAGE OF PEDIATRIC BRONCHOSCOPE. THE PATIENT HAS PARTIAL VIEW OF GLOTTIS. THE FAILURE RESULTED TO DELAY OF TREATMENT. THE PHYSICIAN TRIED THE SCOPE TO ANOTHER NEW FR 39 TUBE TO TEST IF IT ALSO HAD SAME ISSUE AND FOUND THAT THERE WAS ALSO RESISTANCE IN TRACHEAL LUMEN.

  Patient problems: Unintended Extubation

  MAUDE report 13700679 ↗
• MalfunctionJun 11, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DOUBLE-LUMEN'S WHITE BALLOON WAS LEAKING. RE-INTUBATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11986088 ↗
• InjuryJul 2, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THEY NOTICED A VISIBLE HOLE IN THE WALL OF THE 39FR TUBE THAT RESULTED IN A MASSIVE AIR LEAK. RESULTED IN A DELAY OF THE PROCEDURE WAS INDICATED. RE-INTUBATION WAS REQUIRED.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10227544 ↗
• MalfunctionJun 18, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF WAS INFLATABLE, BUT NOT FULL BECAUSE OF LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10167980 ↗
• MalfunctionJun 2, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE¿S SIZE WAS FOUND NOT GOOD WHEREIN SIZE CH 39 WAS USED INSTEAD OF CH 41. IT WAS ALSO STATED THAT AN ERROR MESSAGE APPEARED IN THE RESPIRATOR STATING ¿VACUUM BELLOWS SYSTEM LEAK, CANNOT OPERATE BELLOWS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: No Information

  MAUDE report 10108425 ↗
• InjuryFeb 25, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE WAS UTILIZED FOR THE PATIENT AND THE GLUE ON THE TUBE STARTED COMING LOOSE IN LESS THAN A WEEK. THE PATIENT REQUIRED INTERVENTION.

  Patient problems: Injury

  MAUDE report 9749889 ↗