Shiley 86110Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884522000109), received between May 23, 2018 and Mar 29, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOTED TO HAVE A TEAR IN THE CUFF AND A KINK AT THE DISTAL TIP UPON REMOVAL. THE PATIENT WAS REINTUBATED AND WAS ABLE TO VENTILATE WITHOUT ISSUES POST TUBE EXCHANGE.

  Patient problems: Unintended Extubation

  MAUDE report 16635491 ↗
• MalfunctionJul 11, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF OF THE DEVICE DID NOT INFLATE. REINTUBATION WAS PERFORMED.

  Patient problems: Unintended Extubation

  MAUDE report 14982085 ↗
• MalfunctionDec 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF WAS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115228 ↗
• MalfunctionDec 1, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING THE ADVANCE CHECK, THE CUFF OF THE DEVICE HAD AN AIR LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908825 ↗
• InjuryJun 17, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S NUMBER MARKERS WERE ERASED OR DELETED WHEN SPRAYED BY LIDOCAINE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 10161414 ↗
• MalfunctionMay 19, 2020Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S NUMBER MARKERS WERE ERASED OR DELETED WHEN SPRAYED BY LIDOCAINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10068862 ↗
• MalfunctionSep 2, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8953428 ↗
• MalfunctionJan 3, 2019False Alarm; False Alarm

  ACCORDING TO THE REPORTER, DURING TESTING, THE PROCEDURE COULD NOT BE MADE BECAUSE THE VALVE OF THE TUBE WITH THE BALL WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8214050 ↗
• InjuryMay 23, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE BALLOON WOULD NOT INFLATE ON THE TUBE. IT WAS REPORTED THAT A NEW TUBE WAS OBTAINED. CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 7537073 ↗

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