Mallinckrodt 86452Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 60884522000487), received between Aug 24, 2017 and Apr 9, 2019 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 16, 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.

• InjuryApr 9, 2019Inflation Problem; Leak/Splash; Material Separation; Inflation Problem; Leak/Splash; Material Separation

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED AND THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE AND HAD AIR LEAK. IT WAS REPORTED THAT DEVICE'S CUFF WAS TORN AND WAS FOUND WHEN THE DEVICE WAS REMOVED. THE CUSTOMER REPORTED THAT PATIENT REQUIRED RE-INTUBATION.

  Patient problems: Extubate

  MAUDE report 8495938 ↗
• InjuryApr 9, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED AND THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT DEVICE LOST ITS CUFF PRESSURE AND NOTICED AIR LEAKS FEW HOURS AFTER INTUBATION, AND APPEARED TO BE A DEFECT IN THE PILOT BALLOON. THE CUSTOMER REPORTED THAT PATIENT REQUIRED RE-INTUBATION.

  Patient problems: Extubate

  MAUDE report 8495919 ↗
• InjuryMar 25, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED AND THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT DEVICE LOSE ITS CUFF PRESSURE AND NOTICED AIR LEAKS FEW HOURS AFTER INTUBATION, AND APPEARED TO BE A DEFECT IN THE PILOT BALLOON. THE PATIENT REQUIRED RE-INTUBATION.

  Patient problems: Extubate

  MAUDE report 8450295 ↗
• MalfunctionSep 17, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE PRODUCT HAS PIN HOLES AND DEFLATES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 7881309 ↗
• InjuryJul 3, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT A LEAK WAS NOTED IN THE CUFF ONCE INSERTED IN PATIENT. IT WAS REPORTED THAT THERE WAS PERSISTENT LEAK AFTER INFLATING CUFF. THE CUSTOMER REPORTED THAT THE PATIENT WAS RE-INTUBATED. IT WAS REPORTED THAT THE CUFF HAS NO HOLE IN IT WHEN EXAMINED THE DEVICE.

  Patient problems: Extubate

  MAUDE report 7659150 ↗
• MalfunctionApr 20, 2018Device Dislodged or Dislocated

  THE VENT CIRCUIT/BVM CONNECTOR AT THE TOP OF THE ENDOTRACHEAL TUBE IS EASILY DISLODGED FROM THE ETT ITSELF. ANOTHER ETT IS HAVING TO BE USED OR THE TOP OF THE ETT HAS TO BE CUT IN ORDER TO KEEP THE CONNECTOR FROM COMING OUT OF THE TUBE. THE RESPIRATORY DEPARTMENT HAS REPORTED FOUR THAT THEY HAVE ENCOUNTERED IN THE LAST MONTH OR SO. THEY HAVE ALL OCCURRED WITH THE 8.0MM TUBES HOWEVER NONE OF THE TUBES OR PACKING WAS RETAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7446294 ↗
• InjuryAug 24, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED A REPORT THAT THE DIMENSIONS OF THE PRODUCT WERE BLURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION, STATING THE INK OF THE PRODUCT WAS ADHERED TO THE PACKAGING, HOWEVER, THE DOCTOR OBSERVED THE DEFECT WHEN IT WAS BEING PLACED IN THE PATIENT INSIDE TRACHEA. THERE WAS NO PATIENT HARM, HOWEVER, RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 6819120 ↗