Mallinckrodt 18885Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30884521032556), received between Jun 21, 2017 and May 29, 2019 — classified as 5 injuries, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, THE UNIT'S TUBE AND THE CONNECTOR PART WERE EASY TO GET DISCONNECTED, SO ANOTHER TUBE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8652510 ↗
• InjuryFeb 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICES, A CUFF INFLATION/DEFLATION ISSUE OCCURRED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS THOUGH PATIENT HAD TO BE REINTUBATED.

  Patient problems: Extubate

  MAUDE report 7300080 ↗
• InjuryFeb 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICES, A CUFF INFLATION/DEFLATION ISSUE OCCURRED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS THOUGH PATIENT HAD TO BE REINTUBATED.

  Patient problems: Extubate

  MAUDE report 7300068 ↗
• MalfunctionSep 20, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6880642 ↗
• InjuryJul 5, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE TRACH TUBE EXPERIENCED ISSUES WITH CUFF INFLATION/DEFLATION. IT WAS REPORTED THAT THE PATIENT NEED TO BE RE-INTUBATED AND HAD A FIBROSCOPY. THE CUSTOMER REPORTED 2 DEVICES, THIS REPORT IS FOR THE 2ND DEVICE INVOLVED.

  Patient problems: Extubate

  MAUDE report 6687705 ↗
• InjuryJun 26, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING USE, THE TRACHEAL TUBE WAS NOTED TO HAVE A DEFLATED CUFF. CONSERVATIVE MEASURES WERE ATTEMPTED TO MAINTAIN PRESSURE IN CUFF, HOWEVER FAILED. A FAULTY CUFF ON THE TUBE WAS OBSERVED. RE-INCUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Extubate

  MAUDE report 6668675 ↗
• InjuryJun 21, 2017Suction Problem; Suction Problem

  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 Known Impact Or Consequence To Patient

  MAUDE report 6658501 ↗