Mallinckrodt 86451Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 60884522000470), received between Sep 17, 2018 and Sep 10, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE FAILED DURING PROCEDURE. TH CUFF THAT WOULD NOT STAY INFLATED. THE PATIENT WAS ABLE TO VOCALIZE AROUND THE ENDOTRACHEAL TUBE, AND LOW EXPIRATORY VOLUMES WERE OBSERVED. THE ENDOTRACHEAL TUBE WAS SWITCHED OVER A BOUGIE AND NEEDED TO BE REINTUBATED.

  Patient problems: Hypoventilation; Tachycardia; Unintended Extubation

  MAUDE report 23022156 ↗
• InjuryAug 6, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF LEAK. THERE WAS AN AUDITABLE LEAK. IT WAS RESULTED IN HAVING TO CHANGE THE DEVICE.

  Patient problems: Extubate

  MAUDE report 10376231 ↗
• InjuryAug 3, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S BALLOON HAD LEAKAGE AND THE CUFF WAS FAILING. A REPLACEMENT OF THE TUBE HAS BEEN DONE TO THE PATIENT.

  Patient problems: Extubate

  MAUDE report 10359903 ↗
• MalfunctionJul 28, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD FAILED AND HAD A LEAKAGE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331321 ↗
• MalfunctionSep 19, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF LEAKAGE. THE CUSTOMER INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9093319 ↗
• InjuryAug 7, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF LEAKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872316 ↗
• MalfunctionSep 17, 2018Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE UNIT HAD PIN HOLES AND DEFLATED. THERE IS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 7882837 ↗
• InjurySep 17, 2018Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF DEFLATIONS WHEN INTRODUCED INTO THE PATIENT'S TRACHEA. THE CUSTOMER REPORTED THAT AFTER INSPECTION, THEY NOTED A PIN LIKE HOLES IN THE CUFF. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 7881627 ↗
• MalfunctionSep 17, 2018Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE UNIT HAD A LEAK WHEN INTRODUCED TO A PATIENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 7881584 ↗