Mallinckrodt 125032Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30884522008727), received between Mar 23, 2017 and Jun 28, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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.

• MalfunctionJun 28, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8742885 ↗
• MalfunctionDec 2, 2018Partial Blockage; Partial Blockage

  ACCORDING TO THE REPORTER, THE UNIT HAD DEFLATION FAILURE. THERE WAS NO PATIENT HARM AND RECANNULATION/REINTUBATION WAS NOT PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8123225 ↗
• MalfunctionDec 2, 2018Partial Blockage; Partial Blockage

  ACCORDING TO THE REPORTER, THE UNIT HAD DEFLATION FAILURE. THERE WAS NO PATIENT HARM AND RECANNULATION/REINTUBATION WAS NOT PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8123222 ↗
• MalfunctionMay 17, 2018Material Separation; Material Separation

  ACCORDING TO THE REPORTER, PRIOR TO USE ON A PATIENT, THE BRONCHUS BLUE CUFF WAS FOUND TORN. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7523630 ↗
• MalfunctionAug 25, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT THE UNIT HAD A BROKEN CUFF. CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6822937 ↗
• MalfunctionMay 15, 2017Occlusion Within Device; Occlusion Within Device

  MEDTRONIC RECEIVED A REPORT REGARDING AN ENDOBRONCHIAL TUBE. THE CUSTOMER REPORTED THAT WHILE IN USE ON A PATIENT, THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING AND REMOVING THE BRONCHUS FIBER. CUSTOMER INDICATED THERE WAS NO PATIENT INJURY WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567878 ↗
• MalfunctionMar 23, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT THE TRACHEAL CUFF WOULD NOT DEFLATE. CUSTOMER INDICATED THE ISSUE WAS FOUND DURING PRE-TEST, PRIOR TO PATIENT USE.

  Patient problems: No Patient Involvement

  MAUDE report 6430392 ↗