Mallinckrodt 86050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50884522005676), received between Jan 30, 2018 and Jan 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2018Air Leak; Defective Device

  ANESTHESIA CALLED FOR DIFFICULT INTUBATION. INTUBATED WITH 6.5 CUFFED ETT, UPON PLACING PATIENT ON SERVO, PATIENT QUICKLY DESATURATED AND AIR NOTED TO BE ESCAPING AROUND TUBE. ANESTHESIA CALLED BACK FOR RE-INTUBATION DUE TO DEFECTIVE ETT CUFF. DEFECTIVE TUBE GIVEN TO CHARGE RN.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7227327 ↗

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