Shiley 86111Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884522000116), received between Apr 20, 2018 and Jan 13, 2026 — classified as 10 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THERE WERE ERRORS WITH PROPER INFLATION OF THE ENDOTRACHEAL TUBE'S CUFFS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24059360 ↗
• InjuryOct 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING INTUBATION WITH A ENDOTRACHEAL TUBE, 7CC OF AIR WAS USED TO INFLATE THE ENDOTRACHEAL TUBE CUFF. APPROXIMATELY 15-20 MINUTES LATER, A "POP" SOUND WAS HEARD, FOLLOWED BY THE PATIENT GURGLING AND A SUDDEN LOSS OF VENTILATION FOR A SHORT TERM OF TIME. THE CUFF OF THE ENDOTRACHEAL TUBE HAD POPPED. THE PATIENT WAS PROMPTLY EXTUBATED AND RE-INTUBATED WITHIN A MINUTE BEFORE SURGERY STARTED. NO FURTHER HARM WAS REPORTED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 23354163 ↗
• MalfunctionMay 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A HOLE DIRECTLY ABOVE THE PILOT VALVE INSERTION POINT. THE PATIENT WAS REINTUBATED AND AFTER EXTUBATION THE TUBE WAS EXAMINED TO FIND A HOLE.

  Patient problems: Unintended Extubation

  MAUDE report 21961010 ↗
• MalfunctionApr 1, 2025Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  NOT MANUFACTURED OR DISTRIBUTED BY MEDTRONIC: THE INFORMATION PROVIDED WITHIN THIS RECORD IS REGARDING A PRODUCT THAT WAS NOT MANUFACTURED OR DISTRIBUTED BY MEDTRONIC. THE MANUFACTURER HAS BEEN NOTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738238 ↗
• MalfunctionMar 28, 2025Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  NOT MANUFACTURED OR DISTRIBUTED BY MEDTRONIC: THE INFORMATION PROVIDED WITHIN THIS RECORD IS REGARDING A PRODUCT THAT WAS NOT MANUFACTURED OR DISTRIBUTED BY MEDTRONIC. THE MANUFACTURER HAS BEEN NOTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724300 ↗
• MalfunctionDec 6, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CO2 SAMPLING PORT OF THE FILTER WAS DAMAGED, AND IT WAS REPLACED WITH A NEW ONE. IT WAS ALSO REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863240 ↗
• MalfunctionSep 30, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE  HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339387 ↗
• MalfunctionJul 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, A SMALL PIECE OF PLASTIC CAME OFF OF THE ENDOTRACHEAL TUBE AND STICK TO THE BALLOON PRESSURE MONITOR FILTER THAT RESULTED TO NOT BEING ABLE TO ADD OR REMOVE AIR FROM THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841051 ↗
• MalfunctionMay 15, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, ABOUT FOUR HOURS AFTER PATIENT INTUBATION, THE AIR CAME OUT OF THE CUFF, AND THE VENTILATOR LEAK ALARM SOUNDED. WHEN THE TUBE WAS EXTUBATED FROM THE PATIENT AND PLACED IN WATER, IT WAS FOUND THAT THERE WAS A PINHOLE IN THE UPPER PART OF THE CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 19322827 ↗
• MalfunctionApr 22, 2024Patient-Device Incompatibility; Material Split, Cut or Torn; Patient-Device Incompatibility; Material Split, Cut or Torn

  ACCORDING TO REPORTER, THE ENDOTRACHEAL TUBE WAS REMOVED AFTER THE PATIENT WAS PLACED IN PRONE POSITION, THE CUFF PART WAS DETACHED. THE PATIENT WAS RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 19157479 ↗
• MalfunctionMar 25, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS AN AUDIBLE LEAK AND THE PROVIDERS ATTEMPTED TO ADD AIR TO THE CUFF BUT WERE UNABLE TO INFLATE ADDITIONAL VOLUME. THE PATIENT HAD TO REINTUBATED WITH A NEW ENDOTRACHEAL TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 18970234 ↗
• MalfunctionOct 11, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON WAS BROKEN WHEN THE WRAPPER WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912796 ↗
• MalfunctionSep 13, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE HAD TWO HOLES IN DIFFERENT PLACES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17737646 ↗
• MalfunctionAug 7, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S PILOT BALLOON WAS LEAKING BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477130 ↗
• MalfunctionApr 14, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE DURING THE PROCEDURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 16746538 ↗
• MalfunctionMar 17, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION OR DEFLATION ISSUE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564569 ↗
• MalfunctionOct 11, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PILOT BALLOON HAD AN INFLATION/DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT HARM.

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

  MAUDE report 15577374 ↗
• MalfunctionOct 3, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS SUCCESSFULLY INTUBATED WITH A PREVIOUSLY TESTED ENDOTRACHEAL TUBE. WHEN INFLATING THE CUFF TO INITIATE MECHANICAL VENTILATION, EVIDENCE OF LEAKAGE FROM THE MACHINE WAS OBSERVED. IT WAS IDENTIFIED THAT THE CUFF LOSES PRESSURE SO IT WAS RE-INFLATED BUT STILL CONTINUED TO LEAK. THE ETT WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 15528331 ↗
• MalfunctionJul 14, 2022Crack; Crack

  ACCORDING TO THE REPORTER, THERE WAS A CRACK IN THE ET TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15016837 ↗
• MalfunctionMay 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S PILOT BALLOON WOULD NOT INFLATE. PERFORATION WAS REPORTED IN THE HOSE OR EXTENSION OF INSUFFLATION LINE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 14317699 ↗
• MalfunctionNov 1, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE ON THE PATIENT, THE CUFF, BALLOON AND PILOT VALVE OF THE DEVICE WOULD NOT STAY INFLATED AND DEFLATED. THIRD TUBE WITH DIFFERENT LOT NUMBER WAS USED AND HAD NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727896 ↗
• MalfunctionNov 1, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE ON THE PATIENT, THE CUFF, BALLOON AND PILOT VALVE OF THE DEVICE WOULD NOT STAY INFLATED AND DEFLATED. THIRD TUBE WITH DIFFERENT LOT NUMBER WAS USED AND HAD NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727845 ↗
• InjuryJul 13, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS FOUND TO BE BENT IN HALF. THE PATIENT HAD A SAT OF 82% TUBE STRAIGHTENED AND PATIENT PLACED ON 100% FIO2. THERE WAS PATIENT HARM ASSOCIATED TO THIS EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12159275 ↗
• MalfunctionJun 21, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CRACKED CONNECTOR PART OF THE PILOT BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030512 ↗
• MalfunctionJun 11, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED WITH A 7.0MM TUBE AND THE PLACEMENT WAS CONFIRMED IN A PROPER POSITION. HOWEVER, WHEN THEY BEGAN TO BAG THE PATIENT, THERE WAS A BLOCKAGE THAT DID NOT ALLOW AIR TO PASS THROUGH. THEY TRIED ANOTHER AMBU BAG AND STILL COULD NOT PUSH AIR SO AN AIRWAY EXCHANGE WAS DONE TO ESTABLISH THE PATIENT AIRWAY. THE BLOCKAGE WAS REPORTED TO BE A KINK OF THE TUBE IN THE CENTER OF WHERE THE CUFF LIES ON THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 11988211 ↗

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