Shiley 86043Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884522005616), received between Sep 15, 2022 and Jun 14, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF DEFLATED, BUT THE PILOT LINE BALLOON WAS FOUND RE-INFLATED THREE TIMES, AND THE AIR WAS REMOVED EACH TIME. THE PATIENT WAS EXTUBATED, BUT THE CUFF CONTINUED TO RE-INFLATE AND WAS FOUND WRINKLED UPON TUBE REMOVAL. THE PATIENT DEVELOPED POST-EXTUBATION STRIDOR THAT REQUIRED MULTIPLE DOSES OF NEBULIZED RACEMIC EPINEPHRINE TO TREAT IT AND ALSO A NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) POST-EXTUBATION.

  Patient problems: Swelling/ Edema; Unintended Extubation

  MAUDE report 17126536 ↗
• MalfunctionApr 25, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE' CUFF WAS SPONTANEOUSLY BEING RE-INFLATED BUT STILL DEFLATED. THE TUBE WAS REPLACED.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16809903 ↗
• MalfunctionApr 25, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE' CUFF WAS SPONTANEOUSLY BEING RE-INFLATED BUT STILL DEFLATED. THE TUBE WAS REPLACED.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16809885 ↗
• MalfunctionApr 25, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF RE-INFLATES EVEN AFTER BEING DEFLATED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 16809847 ↗
• MalfunctionApr 24, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF DEFLATED INSTEAD OF BEING RE-INFLATED DURING USE. THE PATIENT EXPERIENCED STRIDOR AND WAS RESOLVED THE NEXT DAY AFTER REINTUBATION.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 16799983 ↗
• MalfunctionSep 15, 2022Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE, THE HEALTHCARE PROFESSIONAL NOTICED THAT THE OUTPUT NUMBERS WAS NOT MAKING SENSE. DURING A CHECK THRU, IT WAS FOUND THAT THE TUBE WAS NOT PROPERLY SEALED AND THE TUBE WAS SPLIT WHERE THE 15MM CONNECTION PIECE FITS IN. REINTUBATION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 15426808 ↗

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