Mallinckrodt 126037 (UDI 10884522028967)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884522028967), received between Aug 24, 2017 and Sep 17, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (29 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809485 ↗
• MalfunctionFeb 10, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCO CATHETER DID NOT INFLATE PRIOR TO USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302956 ↗
• MalfunctionNov 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USE INSPECTION BRONCO CATHETER, THE CUFF COULD NOT BE INFLATED DUE TO AIR LEAKAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532944 ↗
• MalfunctionNov 6, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE CUFF THE FIRST HAD A CRACK AND THE SECOND DEVICE HAD A HOLE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490245 ↗
• MalfunctionSep 18, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCHO CATHETER TUBE HAD AN AIR LEAK WHEN TESTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080969 ↗
• MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS IMPLANTED BEFORE THE OPERATION, AND THE CUFF WAS FOUND TO BE LEAKING AIR. THE MEDICAL STAFF REPLACED THE TUBE A SECOND TIME WITH NO HARM CAUSED TO THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 23021936 ↗
• MalfunctionSep 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A DOUBLE-LUMEN ENDOBRONCHIAL TUBE WAS IMPLANTED BEFORE THE OPERATION, AND THE CUFF WAS FOUND TO BE LEAKING AIR. THE MEDICAL STAFF REPLACED THE TUBE A SECOND TIME WITH NO HARM CAUSED TO THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 23020510 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ANESTHESIOLOGIST INJECTED AIR INTO THE CUFF DURING INTUBATION BUT FOUND NO PRESSURE IN THE CUFF, INDICATING A LEAK. THE TUBE WAS REPLACED, AND THE NEW TUBE FUNCTIONED PROPERLY, ALLOWING THE SURGERY TO PROCEED SMOOTHLY.

  Patient problems: Unintended Extubation

  MAUDE report 22898831 ↗
• 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 22816098 ↗
• MalfunctionAug 6, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS CUFF AIR LEAKAGE DURING THE INFLATION AND DEFLATION TEST WITH THE TWO BRONCO CATHETER AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730275 ↗
• MalfunctionJul 23, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE BRONCHO CATHETER TUBE HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573824 ↗
• MalfunctionJun 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE 37FR BRONCO CATHETER EXPERIENCED ISSUES WITH CUFF INFLATION AND DEFLATION PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22232575 ↗
• MalfunctionJun 16, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE, TWO DOUBLE LUMEN'S TRACHEAL CUFF SEAL HAD FAILED AFTER THE RIGHT INSERTION, WHEN THE TRACHEAL SIDE OPTI-PORT WAS OPENED, AN AIR LEAK OCCURRED. THE TUBES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214131 ↗
• MalfunctionJun 16, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE, TWO DOUBLE LUMEN'S TRACHEAL CUFF SEAL HAD FAILED AFTER THE RIGHT INSERTION, WHEN THE TRACHEAL SIDE OPTI-PORT WAS OPENED, AN AIR LEAK OCCURRED. THE TUBES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213203 ↗
• MalfunctionMar 13, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN CHECKING THE CUFF OF THE FIRST BRONCO CATHETER, IT WAS FOUND THAT THE MAIN CUFF FAILED TO FILL AND DEFLATE. WHILE, THE SECOND BRONCO CATHETER HAD A MISSING CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591554 ↗
• MalfunctionFeb 7, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUFF LEAK WAS DETECTED IN A 37FR RT BRONCO CATHETER BEFORE USE AT A HOSPITAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332128 ↗
• MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, AN AIR LEAK WAS FOUND IN THE CUFF OF THE BRONCO CATHETER DURING THE TEST PHASE BEFORE LUBRICATION WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991292 ↗
• MalfunctionAug 13, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE AND BRONCO CATHETER HAD LEAKS DURING THE PREOPERATIVE TEST AND WERE NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971137 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE PART OF THE BALLOON WAS FOUND TORN AND THE CUFF HAD INFLATION AND DEFLATION ISSUE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311868 ↗
• MalfunctionDec 15, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE FIRST BRONCO CATHETER'S CUFF DID NOT INFLATE AND THE SECOND HAD A BUG LIKE OBJECT FOUND INSIDE THE PACKAGING BEFORE USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340645 ↗
• MalfunctionNov 15, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF ON ONE SIDE OF THE BRONCO CATHETER DID NOT INFLATE. REPLACEMENT OF THE TUBE WAS DONE IMMEDIATELY WITH THE SAME MODEL.

  Patient problems: Unintended Extubation

  MAUDE report 18142796 ↗
• MalfunctionSep 8, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S BRONCHIAL CUFF WAS INFLATED BEFORE USE BUT WAS UNABLE TO DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714957 ↗
• MalfunctionAug 23, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE BRONCO CATHETER'S CUFF HAD A BREAKAGE AND LEAK DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607192 ↗
• MalfunctionApr 28, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, AN AIR LEAK FOUND IN TUBE'S CUFF BEFORE INTUBATION, A NEW TUBE HAD BEEN REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 16834223 ↗
• MalfunctionJan 26, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS TESTED WITH 10ML SYRINGE TO INFLATE AND DEFLATE. DURING THE OPERATION, THE CUFF WAS FOUND TO BE LEAKING. AFTER THE TUBE WAS PULLED OUT, THE MAIN CUFF WAS INFLATED AGAIN, AND THE MAIN CUFF LEAKED SLOWLY. THERE WAS A REQUIRED TUBE REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 16246455 ↗