Mallinckrodt 18870Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30884521032525), received between Apr 11, 2017 and Mar 21, 2021 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS PRE TESTED. ON FRICTION OF THE CUFF WITH THE HAND, THE DEVICE BURST. THE PATIENT WAS A COVID PATIENT. IT WAS INDICATED THAT REPLACEMENT OF TUBE WAS REQUIRED. NO PATIENT CONSEQUENCES. .

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

  MAUDE report 11537011 ↗
• MalfunctionMar 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS PRE TESTED. ON FRICTION OF THE CUFF WITH THE HAND, THE DEVICE BURST. THE PATIENT WAS A COVID PATIENT. IT WAS INDICATED THAT REPLACEMENT OF TUBE WAS REQUIRED. NO PATIENT CONSEQUENCES.

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

  MAUDE report 11537010 ↗
• MalfunctionMar 21, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE WAS PRE TESTED OKAY BUT ONE HOUR LATER, THE CUFF WAS DEFECTIVE. A HOLE WAS FUND IN THE CUFF. IT HAS BEEN NECESSARY TO RE-INTUBATE THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 11537009 ↗
• MalfunctionApr 22, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE¿S CUFF WAS TORN. A NEW DEVICE WAS PREPARED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986427 ↗
• MalfunctionMar 24, 2020Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING USE, THE VENTILATION VOLUME DECREASED. THERE WAS NO LEAKAGE ON THE CIRCUIT OF THE VENTILATOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876103 ↗
• MalfunctionMar 9, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD WRONG SIZE WAS PACKAGED. A PACKAGED LABELED AS SIZE 7.0MM BUT SIZE WAS 7.5MM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9809039 ↗
• InjuryMay 15, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, CUFF LEAKAGE WAS FOUND DURING INTUBATION MANAGEMENT. IT WAS INDICATED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 8613058 ↗
• InjuryApr 11, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, A FEW HOURS (TIME UNKNOWN) AFTER THE INTUBATION, THE VENTILATOR'S LOW PRESSURE ALARM WAS HEARD. WHEN CHECKING THE TUBE, THE NURSE FOUND THAT THE ENDOTRACHEAL TUBE AND THE 15MM SLIP JOINT PART (CONNECTOR) WERE DISCONNECTED. DISCONNECTION OCCURRED SEVERAL TIMES, SO THE PATIENT WAS MOVED FROM THE WARD TO ICU AND WAS MANAGED. IT WAS DETERMINED TO CHANGE TO TRACHEOSTOMY AND THE TUBE WAS REPLACED.

  Patient problems: Extubate

  MAUDE report 8505814 ↗
• InjuryApr 3, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, THE AIR WAS UNABLE TO BE INJECTED FROM THE PILOT BALLOON. THE DEVICE WAS REPLACED TO SOLVE THE ISSUE.

  Patient problems: Extubate

  MAUDE report 8478895 ↗
• InjuryMay 23, 2018Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHILE USE ON A PATIENT, A PIN HOLE WAS FOUND ON THE UPPER PART OF THE CUFF. IT WAS REPORTED THAT THE CUFF WAS SOAKED IN WATER FOR TESTING. THE CUSTOMER INDICATED THERE WAS NO PATIENT HARM.

  Patient problems: Extubate

  MAUDE report 7538361 ↗
• MalfunctionMay 18, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHILE IN USE ON A PATIENT, SOMETIME AFTER INTUBATION, AIR WAS SUPPLIED TO THE CUFF BUT THE DEVICE¿S CUFF WAS NOT INFLATED. RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 7526027 ↗
• MalfunctionNov 16, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT ACCORDING TO THE REPORTER, THERE WAS RESISTANCE AND THE CUFF DID NOT INFLATE DURING THE PRES-TEST. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7037762 ↗
• InjuryNov 15, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING A CUFF INFLATION/DEFLATION ISSUE. THE CUSTOMER INDICATED THAT THE DEVICE WAS REMOVED DUE TO THE CUFF INFLATION/DEFLATION ISSUE BUT THERE WERE NO FURTHER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Extubate

  MAUDE report 7034229 ↗
• MalfunctionJul 31, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, FOREIGN MATTER LIKE AN EYELASH OR HAIR WAS FOUND INSIDE THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6756195 ↗
• InjuryJul 14, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING A PILOT BALLOON. ACCORDING TO THE REPORTER, THERE WAS A CUFF INFLATION/DEFLATION ISSUE.

  Patient problems: Extubate

  MAUDE report 6716206 ↗
• InjuryJun 20, 2017Air Leak; Air Leak

  MEDTRONIC RECEIVED A REPORT THE TRACHEOSTOMY TUBE WAS LEAKING AROUND THE CUFF AND SUB GLOTTIS SECRETION DRAINAGE PORT. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

  Patient problems: No Information

  MAUDE report 6654707 ↗
• InjuryJun 20, 2017Air Leak; Air Leak

  MEDTRONIC RECEIVED A REPORT THE TRACHEOSTOMY TUBE WAS LEAKING AROUND THE CUFF AND SUB GLOTTIS SECRETION DRAINAGE PORT. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

  Patient problems: No Information

  MAUDE report 6654674 ↗
• InjuryJun 20, 2017Air Leak; Air Leak

  MEDTRONIC RECEIVED A REPORT THE TRACHEOSTOMY TUBE WAS LEAKING AROUND THE CUFF AND SUB GLOTTIS SECRETION DRAINAGE PORT. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

  Patient problems: No Information

  MAUDE report 6654673 ↗
• InjuryJun 19, 2017Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TAPERGUARD HAS A RUPTURE TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 6652507 ↗
• MalfunctionApr 24, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT ALLEGING THAT PRIOR TO USE ON A PATIENT, WHILE CHECKING THE CUFF, AIR COULD NOT BE INJECTED FROM THE CUFF. NO PATIENT INVOLVEMENT. THE INFORMATION PROVIDED INDICATES THAT THE SAMPLE WILL BE RETURNING FOR ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 6517592 ↗
• InjuryApr 11, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE TWO ENDOTRACHEAL TUBES WERE OBSERVED TO HAVE A CUFF LEAK. CUSTOMER INDICATED THERE WAS NO INJURY TO PATIENT.

  Patient problems: Extubate

  MAUDE report 6483704 ↗