Mallinckrodt 86234Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521212848), received between Oct 10, 2017 and Nov 13, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2020Installation-Related Problem; Physical Resistance/Sticking; Installation-Related Problem; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, WHEN USING THE PEDIATRIC TRACHEAL TUBE AND THE Y CONNECTOR 3.0, THE SUCTION TUBE WAS STUCK INSIDE THE TRACHEAL TUBE AND IT DID NOT ADVANCE. REINTUBATION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; Unintended Extubation

  MAUDE report 10837161 ↗
• InjuryJun 18, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS USING THE TUBE 8 HOURS PRIOR TO THE INCIDENT WHEREIN THE DEVICE WAS NOTICED TO BE MISSING THE 6 CM MARK. IT WAS REPORTED THAT THE TUBE WAS PLACED IN THE PATIENT AND WAS THEN EXTUBATED. IT WAS SUSPECTED THAT THE TUBE MIGHT HAVE BEEN PLACED INCORRECTLY DUE TO THE MISSING MARK. THE PATIENT WAS REINTUBATED USING UNCUFFED ENDOTRACHEAL TUBE AND RECEIVED MECHANICAL VENTILATION.

  Patient problems: Extubate

  MAUDE report 7611163 ↗
• InjuryApr 24, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED AND THE TUBE HAD BEEN IN FOR 5 DAYS. IT WAS REPORTED THAT THE #6 COULD NOT BE SEEN AT THE LIP OF THE BABY BECAUSE THE NUMBER HAD WORN OFF. IT WAS STATED THAT THE TUBE WAS NOT KEPT BUT THEY OPENED ANOTHER TUBE. THE RESPIRATORY THERAPY SUPERVISOR WAS ABLE TO RUB OFF THE NUMBERING WITH THEIR FINGERNAIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454943 ↗
• InjuryApr 19, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, THE MARKINGS ON THE TUBE WERE RUBBING OFF WITH NORMAL USE. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY IN THIS EVENT AND PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7444702 ↗
• InjuryOct 10, 2017Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED A REPORT THAT TWO DAYS AFTER THE ENDOTRACHEAL TUBE WAS PLACED IN THE PATIENT THE NUMBERS WERE RUBBING OFF AND IT WAS DIFFICULT TO SEE IF PATIENT WAS STILL INTUBATED. THE CUSTOMER COULD NOT PROVIDE THE PATIENT OUTCOME OR ANY INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935679 ↗