Mallinckrodt 18790Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50884522007632), received between Jul 31, 2017 and Nov 3, 2020 — classified as 2 injuries, 2 malfunctions.

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

• InjuryNov 3, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS A FAILURE IN THE ACCURACY OF THE VALVES THAT WAS USED TO INFLATE THE CUFF. AFTER THE INSERTION OF THE TUBE, THERE WAS A CONTINUOUS DROPPING IN SATURATION AS WELL AS AIR LEAK. WHEN PERFORMING EXTUBATION, IT WAS VERIFIED THAT THE CUFF WAS LEAKING.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 10781920 ↗
• InjuryAug 19, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICES HAD CUFF LEAKAGE. THE PATIENT HAD AN IMMEDIATE TUBE EXCHANGED.

  Patient problems: Extubate

  MAUDE report 10426441 ↗
• MalfunctionDec 20, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, BEFORE USE, THE UNIT'S CUFF WAS FOUND DAMAGED AND CRACKED DURING CUFF CHECK. IT WAS REPORTED THAT ANOTHER PRODUCT WAS OPENED AND USED ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9503600 ↗
• 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 6756181 ↗