Mallinckrodt 86112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 40884522000124), received between Aug 11, 2017 and Aug 25, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

1 other recall cover devices cleared under the same FDA submission (K871204); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF LEAK IMMEDIATELY WHEN INTUBATED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8928908 ↗
• InjuryApr 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF DID NOT INFLATE WHEN AN AIR WAS PUSHED. THE CUSTOMER INDICATED THAT THE PATIENT HAD TO BE RE-CANNULATED WITH A NEW TUBE.

  Patient problems: Extubate

  MAUDE report 7443617 ↗
• MalfunctionAug 11, 2017Contamination; Contamination

  MEDTRONIC RECEIVED A COMMUNICATION THAT THE TUBE PACKING WAS FOUND TO HAVE A HAIR. THE CUSTOMER INDICATED THAT THERE WERE NO INJURIES OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6790372 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K871204. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2023 · Feb 10, 2023 · Open, Classified
  COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal in