Shiley 86053Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 20884522000267), received between Sep 1, 2017 and Jun 19, 2025 — classified as 2 deaths, 8 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (15 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT CUFF OF THE ENDOTRACHEAL TUBE HAD INFLATION AND DEFLATION ISSUES DURING USE IN A HOSPITAL SETTING. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22290761 ↗
• MalfunctionMay 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE WOULD NOT STAY INFLATED WHILE IN A PATIENT. THE TUBE WAS REPLACED WITH THE SAME SIZE OF TUBE BUT THE CUFF WOULD NOT STAY INFLATED AGAIN. REPLACED THE TUBE WITH A DIFFERENT SIZE WHICH STAYED INFLATED.

  Patient problems: Unintended Extubation

  MAUDE report 19310309 ↗
• MalfunctionMay 14, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE ENDOTRACHEAL TUBE WOULD NOT STAY INFLATED WHILE IN A PATIENT. THE TUBE WAS REPLACED WITH THE SAME SIZE OF TUBE BUT THE CUFF WOULD NOT STAY INFLATED AGAIN. REPLACED THE TUBE WITH A DIFFERENT SIZE WHICH STAYED INFLATED.

  Patient problems: Unintended Extubation

  MAUDE report 19310306 ↗
• MalfunctionMay 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED WITH A SIZE 8 ENDOTRACHEAL TUBE AND WOULD NOT STAY INFLATED. THE TUBE WAS REPLACE WITH ANOTHER SIZE 8 AND AGAIN IT DID NOT STAY INFLATED. THE TUBE WAS REPLACED AGAIN WITH A SIZE 7.5 TUBE AND STAYED INFLATED.

  Patient problems: Unintended Extubation

  MAUDE report 19269240 ↗
• MalfunctionMay 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED WITH A SIZE 8 ENDOTRACHEAL TUBE AND WOULD NOT STAY INFLATED. THE TUBE WAS REPLACE WITH ANOTHER SIZE 8 AND AGAIN IT DID NOT STAY INFLATED. THE TUBE WAS REPLACED AGAIN WITH A SIZE 7.5 TUBE AND STAYED INFLATED.

  Patient problems: Unintended Extubation

  MAUDE report 19269174 ↗
• DeathDec 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A SMALL LEAK INITIALLY NOTICED AROUND THE ENDOTRACHEAL TUBE, WHICH WORSENED THE FOLLOWING DAY, REQUIRING A TUBE EXCHANGE BY ANESTHESIA. THE PATIENT WAS IN A CRITICAL CONDITION, COMPROMISED DURING TUBE EXCHANGE, AND WAS PARALYZED, WHICH TOOK APPROXIMATELY 10 SECONDS. THE PATIENT THEN CODED 'FOR QUITE SOME TIME' AND EVENTUALLY EXPIRED.

  Patient problems: Unintended Extubation

  MAUDE report 18422493 ↗
• MalfunctionDec 28, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE LEAKED WITH A VISIBLE HOLE IN THE BALLOON DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 18416038 ↗
• DeathDec 15, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED DURING A CARDIAC ARREST AND THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK. THE FAMILY DECIDED ORDERED "DO NOT RESUSCITATE" DNR AND THE PATIENT EXPIRED.

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 18341347 ↗
• MalfunctionDec 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S BALLOON WOULD NOT DEFLATE WHEN ATTEMPTING TO REMOVED FROM THE PATIENT. SIMILAR ISSUE WAS ALSO OBSERVED RECENTLY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Unintended Extubation

  MAUDE report 18328878 ↗
• MalfunctionDec 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S BALLOON WOULD NOT DEFLATE WHEN ATTEMPTING TO REMOVED FROM THE PATIENT. SIMILAR ISSUE WAS ALSO OBSERVED RECENTLY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18328809 ↗
• MalfunctionDec 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A LEAK AROUND THE ENDOTRACHEAL TUBE. THE TUBE WAS REPOSITIONED AND WAS ABLE TO SEAL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18326445 ↗
• MalfunctionNov 8, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE CUFF WAS PRE-TESTED AND DID NOT INFLATE/DEFLATE. THE CUFF WAS NOT HOLDING AIR. THE TUBE HAS BEEN REPLACED. THE PATIENT HAD NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757013 ↗
• InjurySep 15, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THREE TUBES HAD CUFF INFLATION ISSUES DUE TO CUFF LEAKS. THE FIRST TUBE WAS NOT TESTED. THE PATIENT WAS INTUBATED UTILIZING A BOUGIE AND IT WAS REALIZED THAT THERE WAS A LEAK. THE SECOND TUBE WAS TESTED BY INFLATION WITH A SYRINGE. THE CUFF APPEARED TO WORK. THE PATIENT WAS INTUBATED AND THE CUFF WAS INFLATED BUT IT WAS REALIZED THAT THE CUFF STARTED LEAKING AND IT DEFLATED. THE THIRD TUBE WAS TESTED BY INFLATION WITH A SYRINGE AND IT IMMEDIATELY BEGAN TO DEFLATE. THE DEVICE WAS NOT USED FOR INTUBATION. THE FOURTH TUBE WAS TESTED BY INFLATION WITH A SYRINGE AND THE PATIENT WAS INTUBATED SUCCESSFULLY. THE PATIENT SUBSEQUENTLY EXPIRED THE FOLLOWING DAY AND IT WAS REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. THE PATIENT HAD END STAGE CONGESTIVE HEART FAILURE.

  Patient problems: Unintended Extubation

  MAUDE report 15433454 ↗
• InjurySep 6, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THREE TUBES HAD CUFF INFLATION ISSUES DUE TO CUFF LEAKS. THE FIRST TUBE WAS NOT TESTED. THE PATIENT WAS INTUBATED UTILIZING A BOUGIE AND IT WAS REALIZED THAT THERE WAS A LEAK. THE SECOND TUBE WAS TESTED BY INFLATION WITH A SYRINGE. THE CUFF APPEARED TO WORK. THE PATIENT WAS INTUBATED AND THE CUFF WAS INFLATED BUT IT WAS REALIZED THAT THE CUFF STARTED LEAKING AND IT DEFLATED. THE THIRD TUBE WAS TESTED BY INFLATION WITH A SYRINGE AND IT IMMEDIATELY BEGAN TO DEFLATE. THE DEVICE WAS NOT USED FOR INTUBATION. THE FOURTH TUBE WAS TESTED BY INFLATION WITH A SYRINGE AND THE PATIENT WAS INTUBATED SUCCESSFULLY. THE PATIENT WAS DECEASED BUT NOT DUE TO THE DEVICE ISSUE. THE PATIENT HAD END STAGE CONGESTIVE HEART FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 15363478 ↗
• InjurySep 6, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THREE TUBES HAD CUFF INFLATION ISSUES DUE TO CUFF LEAKS. THE FIRST TUBE WAS NOT TESTED. THE PATIENT WAS INTUBATED UTILIZING A BOUGIE AND IT WAS REALIZED THAT THERE WAS A LEAK. THE SECOND TUBE WAS TESTED BY INFLATION WITH A SYRINGE. THE CUFF APPEARED TO WORK. THE PATIENT WAS INTUBATED AND THE CUFF WAS INFLATED BUT IT WAS REALIZED THAT THE CUFF STARTED LEAKING AND IT DEFLATED. THE THIRD TUBE WAS TESTED BY INFLATION WITH A SYRINGE AND IT IMMEDIATELY BEGAN TO DEFLATE. THE DEVICE WAS NOT USED FOR INTUBATION. THE FOURTH TUBE WAS TESTED BY INFLATION WITH A SYRINGE AND THE PATIENT WAS INTUBATED SUCCESSFULLY. THE PATIENT WAS DECEASED BUT NOT DUE TO THE DEVICE ISSUE. THE PATIENT HAD END STAGE CONGESTIVE HEART FAILURE.

  Patient problems: Unintended Extubation

  MAUDE report 15363460 ↗
• MalfunctionDec 27, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF WOULD NOT STAY INFLATED WHEN PLACED IN PATIENT. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 13088104 ↗
• MalfunctionJul 26, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, IN ALL INSTANCES THE CUFF WAS CHECKED BEFORE INTUBATION BUT THEN COULD NOT HOLD AIR AFTER INTUBATION. THERE WAS NO REPORTED ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224556 ↗
• MalfunctionJul 25, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT HOLD AIR ONCE INSERTED. PATIENT OXYGEN SATURATION (SPO2) DROPPED DUE TO LOST OF POSITIVE END-EXPIRATORY PRESSURE (PEEP). THE PATIENT WAS REINTUBATED.

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

  MAUDE report 12223104 ↗
• MalfunctionJul 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, IN ALL INSTANCES THE CUFF WAS CHECKED BEFORE INTUBATION BUT THEN COULD NOT HOLD AIR AFTER INTUBATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218825 ↗
• MalfunctionJul 22, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT HOLD AIR ONCE INSERTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12213144 ↗
• InjuryJul 22, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT HOLD AIR ONCE INSERTED. NO LUBRICANT WAS USED BECAUSE THE PATIENT HAD EXCESSIVE BLOODY SECRETIONS. DESATURATION WAS RECOVERED AFTER REINTUBATION.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 12213065 ↗
• MalfunctionJul 7, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT INFLATE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12130664 ↗
• MalfunctionMar 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PRODUCT WOULD NOT DEFLATE DURING NORMAL EXTUBATION. A BRONCH WAS USED TO PUNCTURE THE CUFF IN ORDER TO REMOVE WITH BOUGIE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558736 ↗
• MalfunctionMar 16, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS NOT HOLDING AIR. THE PATIENT WAS REINTUBATED BUT NO HARM.

  Patient problems: Unintended Extubation

  MAUDE report 11494208 ↗
• InjuryDec 15, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, BALLOON WAS NOT INFLATING PROPERLY AND/OR THE TUBE BREAKING. IT WAS INDICATED THAT POSSIBLE REINTUBATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11012241 ↗

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