Shiley 86234 (UDI 10884521620254)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521620254), received between May 24, 2019 and Dec 20, 2023 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Defective Component” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S MARKINGS WORE OFF DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18363237 ↗
• MalfunctionApr 9, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE DEVICE WAS INSERTED TO SUCK PATIENT'S SPUTUM, BUT IT WAS HARD TO PULL OUT AND FOUND STUCK AT THE ENDOTRACHEAL TUBE. THE PATIENT HAD A REPLACEMENT OF THE TUBE WITH NO HARM.

  Patient problems: Unintended Extubation

  MAUDE report 11641822 ↗
• MalfunctionMar 31, 2021Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE SPUTUM SUCTION TUBE SIZE SIX WAS INSERTED TO SUCK PATIENT'S SPUTUM BUT IT WAS HARD TO PULL OUT AND THE NURSE FELT IT STUCK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596612 ↗
• MalfunctionMar 31, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE DEVICE WAS INSERTED TO SUCK PATIENT'S SPUTUM, BUT IT WAS HARD TO PULL OUT AND FOUND STUCK AT THE ENDOTRACHEAL TUBE. THE PATIENT HAD A REPLACEMENT OF THE TUBE WITH NO HARM.

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

  MAUDE report 11596575 ↗
• MalfunctionMar 15, 2021Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CRACK AT THE END OF THE TUBE TO 15MM CONNECTOR. IT WAS REPORTED THAT WHEN THE 15MM CONNECTOR WAS GOING TO BE CONNECTED TO THE VENTILATOR, THE CRACK WAS FOUND. THE CRACK PART WAS CUT, THEN THE 15 MM CONNECTOR WAS INSERTED INTO THE TUBE AND CONNECTED WITH THE VENTILATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484656 ↗
• InjuryNov 4, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, AFTER INTUBATION, ADAPTER ON ETT SNAPPED AND A PIECE WAS OBSTRUCTING THE ETT. THE PATIENT COULD NOT BE VENTILATED AND STARTED TO DECOMPENSATE. THE TUBE WAS CUT AND REPLACED CAP RESULTING IN PATIENT STABILIZING. THE TUBE REMAINED IN THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10783804 ↗
• MalfunctionOct 23, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE HUB BROKE OFF THE STEM. RATHER THAN REINTUBATE THE PATIENT, WAS ABLE TO USE THE BALLARD ADAPTER. THE STEM IS STUCK INSIDE OF THE ET TUBE. THE DEVICE WAS FRESH FROM THE PACKAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10727749 ↗
• MalfunctionFeb 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USED, THE DEVICE CUFF DEHP MATERIAL CAUSED GLOTTIS SWELLING.

  Patient problems: Swelling

  MAUDE report 9712001 ↗
• InjuryDec 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE MARKING WAS RUBBING OFF. THE CUSTOMER INDICATED THAT THE PATIENT HAD A HIGH RISK FOR TRAUMA OR EXTUBATION AND DEVICE MISMANAGEMENT. THE CUSTOMER INDICATED THAT THE INCIDENT DEVICE HAS BEEN DISCARDED.

  Patient problems: Extubate

  MAUDE report 9503513 ↗
• MalfunctionDec 3, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD TUBE THAT WAS STICKY AND ROUGH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9401439 ↗
• MalfunctionSep 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD STICKY RESIDUE END OF TUBE. CLOUDY, ROUGH SURFACE THROUGHOUT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9040399 ↗
• MalfunctionSep 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD STICKY RESIDUE END OF TUBE. CLOUDY, ROUGH SURFACE THROUGHOUT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9038745 ↗
• MalfunctionSep 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD STICKY RESIDUE END OF TUBE. CLOUDY, ROUGH SURFACE THROUGHOUT. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9038588 ↗
• MalfunctionSep 3, 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 8957502 ↗
• MalfunctionSep 3, 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 8957501 ↗
• MalfunctionSep 3, 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 8957500 ↗
• MalfunctionSep 3, 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 8956874 ↗
• MalfunctionSep 3, 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 8956863 ↗
• MalfunctionSep 3, 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 8956822 ↗
• MalfunctionSep 3, 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 8956782 ↗
• MalfunctionSep 3, 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 8956709 ↗
• MalfunctionSep 3, 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 8956632 ↗
• MalfunctionSep 3, 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 8956588 ↗
• MalfunctionSep 3, 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 8956554 ↗
• MalfunctionSep 3, 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 8956515 ↗