Shiley 18785SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521620216), received between Mar 13, 2018 and Feb 6, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Connection Problem

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR AND A DISPOSABLE CIRCUIT WAS LOOSE. WHEN ANOTHER TUBE WAS USED, THE CONNECTION WAS FIXATED WITHOUT ANY PROBLEMS. ANOTHER TUBE FROM THE HOSPITAL STOCK WAS DISCOVERED THAT HAD THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283272 ↗
• MalfunctionJan 30, 2026Connection Problem

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE ENDOTRACHEAL TUBE'S 15MM CONNECTOR AND A DISPOSABLE CIRCUIT WHEN CONNECTED WAS LOOSE. WHEN ANOTHER TUBE WAS CONNECTED, THE CONNECTION WAS FIXATED WITHOUT ANY PROBLEMS.

  Patient problems: Unintended Extubation

  MAUDE report 24226580 ↗
• MalfunctionDec 3, 2021Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD A CUFF INFLATION/DEFLATION ISSUE AND WAS USED ON THE PATIENT. THERE WAS NO RELATION TO OTHER DEVICES, AND THERE WAS NO HEALTH INJURY.

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

  MAUDE report 12923477 ↗
• MalfunctionOct 8, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, IN THE PRE-USAGE CUFF CHECK, THE UNIT INFLATED. BUT THE CUFF WOULD NOT INFLATE AFTER INTUBATION. THE TRACHEAL TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 12599726 ↗
• MalfunctionAug 30, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388196 ↗
• InjuryDec 8, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS A CUFF LEAKAGE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 10968361 ↗
• MalfunctionOct 11, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS RESISTANCE TO INFLATE THE CUFF DURING CUFF CHECK BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9182261 ↗
• MalfunctionApr 2, 2019Partial Blockage; Partial Blockage

  ACCORDING TO THE REPORTER, THE AIR WAS SUPPLIED AT THE CUFF CHECK PRIOR TO INTUBATION, BUT IT WAS UNABLE TO DEFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8473278 ↗
• MalfunctionMar 12, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE PRE-TEST INSPECTION, THERE WAS RESISTANCE OF THE PILOT BALLOON WHEN THE CUFF CHECK WAS PERFORMED. THE CUFF WAS DIFFICULT TO INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8411740 ↗
• MalfunctionJan 22, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE UNIT DID NOT INFLATE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266568 ↗
• MalfunctionAug 23, 2018Component Missing; Component Missing

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT CONTAIN STYLET. THE CUSTOMER INDICATED NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7809168 ↗
• MalfunctionJul 10, 2018Inflation Problem; Improper Flow or Infusion; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, AIR DID NOT FLOW INTO THE CUFF SMOOTHLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7673428 ↗
• MalfunctionMar 13, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE COULD NOT BE INJECTED WITH AIR AT THE TIME OF THE LEAK TEST. A SECOND ATTEMPT ALSO FAILED. AIR COULD BE INJECTED ON THE THIRD ATTEMPT BUT NEW TUBE WAS OPENED. THE CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7334149 ↗