Mallinckrodt 18750Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30884522007539), received between Apr 27, 2017 and Mar 15, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, TWO ENDOTRACHEAL TUBES HAD CUFF LEAKS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Patient Involvement

  MAUDE report 8426174 ↗
• MalfunctionMar 14, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, TWO ENDOTRACHEAL TUBES HAD CUFF LEAKS. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 8422896 ↗
• MalfunctionSep 25, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, WHILE CHECKING THE CUFF A LEAK WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. YES, THE SAMPLE IS EXPECTED TO BE RETURNED FROM THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 6891683 ↗
• MalfunctionSep 8, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE BEFORE EVEN OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6853769 ↗
• MalfunctionSep 8, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE BEFORE EVEN OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6853731 ↗
• MalfunctionJul 31, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL WAS FOUND INSIDE THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6756193 ↗
• MalfunctionMay 26, 2017Deflation Problem; Deflation Problem

  MEDTRONIC RECEIVED A REPORT REGARDING AN ENDOTRACHEAL TUBE. THE CUSTOMER REPORTED THAT DURING THE PRE-TEST, THE CUFF WOULD NOT DEFLATE COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6595861 ↗
• MalfunctionApr 27, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A REPORT A PIECE OF HAIR WAS FOUND CONTAINED IN THE PACKAGE. CUSTOMER INDICATED ISSUE WAS FOUND PRIOR TO PATIENT USE.

  Patient problems: No Patient Involvement

  MAUDE report 6528587 ↗