Shiley 86052Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 20884522000250), received between Feb 11, 2020 and Jan 6, 2026 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (23 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD RUPTURED PILOT BALLOON AND CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986456 ↗
• MalfunctionApr 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE TYPE OF ENDOTRACHEAL (ET) TUBE DURING A PROCEDURE. THE ANESTHESIA PROVIDER EXTUBATED THE PATIENT WHILE THE CUFF WAS STILL INFLATED, DESPITE THE SYRINGE BEING ATTACHED TO THE INFLATION/DEFLATION PORT AND THE PILOT BALLOON DEFLATING AS EXPECTED. ADDITIONALLY, THE ENDOTRACHEAL TUBE'S CUFF WOULD NOT DEFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767705 ↗
• MalfunctionApr 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING EXTUBATION THE CUFF OF THE ENDOTRACHEAL TUBE REMAINED INFLATED AFTER EXTUBATION. THE ANESTHESIA PROVIDER ATTACHED A SYRINGE TO THE INFLATION/DEFLATION PORT, PULLED BACK THE PLUNGER, AND OBSERVED THE PILOT BALLOON DEFLATE, MAKING IT EASY TO WITHDRAW THE AIR. HOWEVER, UPON EXTUBATION, THE CUFF WAS STILL INFLATED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21751145 ↗
• MalfunctionJun 17, 2024Crack; Crack

  ACCORDING TO THE REPORTER, THE 15MM CONNECTOR WAS FOUND CRACKED IN THE ENDOTRACHEAL TUBE WITH A NON-STYLET, AS SHOWN IN THE ATTACHED PHOTO. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19551405 ↗
• MalfunctionFeb 7, 2024Defective Component; Human-Device Interface Problem; Defective Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE WAS NOT STURDY AND WOULD TWIST AND BEND DURING INTUBATING TO A PATIENT. DOCTOR ALSO MENTIONED THAT THE TUBE WAS TOO OPAQUE TO ACCESS CONDENSATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659073 ↗
• MalfunctionDec 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A LEAK AROUND THE TUBE. THE TUBE HAS NOT BEEN CHANGED YET. THE PATIENT HAS BEEN MADE DNR (DO-NO T-RESUSCITATE) SO THE TUBE WILL BE SAVED WHEN THE PATIENT EXPIRES. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18293497 ↗
• MalfunctionMar 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE HAD AN AIR LEAK DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585600 ↗
• MalfunctionMar 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE HAD AN AIR LEAK DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585543 ↗
• MalfunctionJan 26, 2023Use of Device Problem; Patient-Device Incompatibility; Use of Device Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF RUPTURED THAT REQUIRED PATIENT TO BE REINTUBATED. A SECOND CUFF RUPTURED, WHICH FOLLOWED BY ANOTHER INTUBATION, AND CUFF WOULDN'T HOLD AIR.

  Patient problems: Unintended Extubation

  MAUDE report 16246305 ↗
• MalfunctionJan 26, 2023Use of Device Problem; Patient-Device Incompatibility; Use of Device Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CUFF RUPTURED THAT REQUIRED PATIENT TO BE REINTUBATED. A SECOND CUFF RUPTURED, WHICH FOLLOWED BY ANOTHER INTUBATION, AND CUFF WOULDN'T HOLD AIR.

  Patient problems: Unintended Extubation

  MAUDE report 16246245 ↗
• MalfunctionDec 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TWO DEVICE WAS FAULTY AND HAD INFLATION/DEFLATION ISSUE WHILE THE THIRD DEVICE WOULD NOT INFLATE WHEN TESTED. PATIENT WAS REINTUBATED THREE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13076157 ↗
• MalfunctionDec 20, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED WITH LUBRICATION. THE DEVICE HAD A LEAKING CUFF. REINTUBATION WAS PERFORMED. THE PATIENT DIED DUE TO COMPLICATIONS OF COVID AND NOT RELATED TO THE DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 13042651 ↗
• InjuryDec 20, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TWO DEVICE WAS FAULTY AND HAD INFLATION/DEFLATION ISSUE WHILE THE THIRD DEVICE COULD NOT INFLATE WHEN TESTED. PATIENT WAS REINTUBATED THREE TIMES.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 13042619 ↗
• InjuryDec 20, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE TWO DEVICE WAS FAULTY AND HAD INFLATION/DEFLATION ISSUE WHILE THE THIRD DEVICE COULD NOT INFLATE WHEN TESTED. THE PATIENT WAS REINTUBATED THREE TIMES.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 13042587 ↗
• MalfunctionDec 20, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS FAULTY, IT WAS REPORTED THAT IT HAD INFLATION/DEFLATION ISSUE. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 13042541 ↗
• InjuryNov 23, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S TUBE HAD A KINK WHICH AFFECTED THE PATIENT'S VENTILATION. KINK WAS NOTED AS 15MM MARK. PATIENT WAS MANUALLY BAGGED, AND IT HAD MORE THAN NORMAL RESISTANCE, THE PATIENT WAS THEN SUCTIONS WITH A INLINE SUCTION CATHETER AND THE CATHETER IT SELF WOULD NOT ADVANCE LIKE IT NORMALLY SHOULD. PATIENT HAD EPISODE OF HYPOXIA AND LOW OXYGEN SATURATION. THIS WAS WHEN DECIDED TO EXCHANGE THE TUBE.

  Patient problems: Hypoxia; Insufficient Information; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 12865268 ↗
• MalfunctionJun 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, UPON THE INFLATION OF THE UNIT THE CUFF POPPED A HOLE. THERE WAS A REQUIRED RE-INTUBATION REPORTED.

  Patient problems: Unintended Extubation

  MAUDE report 12047177 ↗
• MalfunctionJun 10, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING INTUBATION, WHEN THE PHYSICIAN BLEW UP THE CUFF, IT POPPED A HOLE IN IT. IN RESULT, THE PATIENT HAD TO BE RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 11975114 ↗
• MalfunctionJun 10, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING INTUBATION, WHEN THE PHYSICIAN BLEW UP THE CUFF, IT POPPED A HOLE IN IT. IN RESULT, THE PATIENT HAD TO BE RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 11975094 ↗
• MalfunctionJun 10, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING INTUBATION, WHEN THE PHYSICIAN BLEW UP THE CUFF, IT POPPED A HOLE IN IT. IN RESULT, THE PATIENT HAD TO BE RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 11975062 ↗
• MalfunctionJun 10, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING INTUBATION, WHEN THE PHYSICIAN BLEW UP THE CUFF, IT POPPED A HOLE IN IT. IN RESULT, THE PATIENT HAD TO BE RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 11975033 ↗
• MalfunctionJun 9, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING INTUBATION, WHEN THE PHYSICIAN BLEW UP THE CUFF, IT POPPED A HOLE IN IT. IN RESULT, THE PATIENT HAD TO RE-INTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 11968580 ↗
• MalfunctionJan 27, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF FAILURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11235429 ↗
• InjuryDec 15, 2020Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON WAS NOT INFLATING AND TUBE WAS BROKEN. THE PATIENT HAD EXCESSIVE SWELLING AND THE DEVICE HAD TO BE CHANGED AND DOWNSIZED BECAUSE OF THE SWELLING. IT WAS UNCLEAR IF THE SWELLING HAD TO DO WITH THE PRESSURE LEAVING THE CUFF. IT WAS ALSO UNCLEAR IF THE REINTUBATION WAS AS A RESULT OF THE SWELLING OR AS A RESULT OF THE DEFLATION OF THE DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 11012776 ↗
• MalfunctionMay 18, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON DID NOT INFLATE WHEN THE PATIENT WAS INTUBATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067839 ↗

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