Shiley 18875 (UDI 40884521032539)Recalls & reported problems

Summary

The FDA's MAUDE database contains 570 adverse event reports that list this exact device (DI 40884521032539), received between Oct 27, 2017 and Sep 21, 2026 — classified as 4 deaths, 160 injuries, 406 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (271 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 570 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50848669 ↗
• MalfunctionSep 16, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794103 ↗
• MalfunctionAug 27, 2026Material Deformation

  It was reported that during use, an endotracheal intubation was performed as ordered by the physician. After the circuit was secured, it was found that the endotracheal tube could not remain upright and tended to fold outward. Manual intervention was provided to keep the circuit in an upright position. The tube was replaced.

  Patient problems: Unintended Extubation

  MAUDE report 50487942 ↗
• InjuryAug 20, 2026Use of Device Problem

  It was reported that the patient¿s dyspnea gradually worsened, but remained conscious with low skin temperature in the extremities and scattered mottling over the body. Therefore, endotracheal intubation and ventilator-assisted ventilation were provided. Before intubation, a routine cuff seal test was performed, which showed cuff leakage. After the endotracheal tube was replaced, the intubation was completed successfully. The event resulted in a delay to treatment and hypoxia because the cuff leak was not detected in time.

  Patient problems: Hypoxia

  MAUDE report 50359821 ↗
• InjuryAug 19, 2026Gas/Air Leak

  Patient problems: Hypoventilation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330910 ↗
• InjuryAug 13, 2026Gas/Air Leak

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 50244300 ↗
• InjuryAug 8, 2026Gas/Air Leak

  It was reported that after the patient developed weak breathing due to intracerebral hemorrhage, endotracheal intubation was ordered by the physician and the intubation was successful. After intubation, the patient was connected to a ventilator for assisted breathing, but the ventilator issued a continuous low-pressure alarm. The alarm persisted even after repeated adjustments, the cuff pressure of the tube was checked and found to be slightly low, then the cuff was inflated. After inflation, the ventilator alarm disappeared then about 2 minutes later, the ventilator again issued a low-pressure alarm, which happened repeatedly. The tube was replaced, and when the removed tube was inspected, it inflated smoothly and the cuff was full. After water was injected into the cuff, continuous water jets were observed from the cuff wall, confirming cuff leakage. The event delayed the patient¿s treatment but no apparent harm.

  Patient problems: Unintended Extubation

  MAUDE report 50184595 ↗
• MalfunctionJul 30, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 50082428 ↗
• InjuryJul 29, 2026Use of Device Problem

  It was reported that before intubation, the physician tested the cuff pressure and found that the cuff could not be inflated. Inspection showed that the cuff had ruptured, and the endotracheal tube was immediately replaced. This prolonged the patient¿s resuscitation time.

  Patient problems: Insufficient Information

  MAUDE report 50068101 ↗
• InjuryJul 16, 2026Material Deformation

  IT WAS REPORTED THAT AFTER THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM, THE PATIENT HAD LOW PERIPHERAL OXYGEN SATURATION AND RHONCHI WERE HEARD IN THE THROAT. BLOOD GAS ANALYSIS SHOWED A PARTIAL PRESSURE OF OXYGEN OF 41 MMHG. TO IMPROVE THE PATIENT¿S VENTILATION AND OXYGENATION, ENDOTRACHEAL INTUBATION WAS PERFORMED. WHEN THE NURSE PERFORMED SUCTION CARE, THERE WAS OBVIOUS RESISTANCE AFTER THE SUCTION CATHETER ENTERED THE ENDOTRACHEAL TUBE. THE PERIPHERAL OXYGEN SATURATION DECREASED TO 88%, AND THE VENTILATOR TIDAL VOLUME FLUCTUATED WITHIN THE RANGE OF 200¿320 ML. TO ASSESS THE CONDITION OF THE ENDOTRACHEAL TUBE AND LUNGS AND TO ASSIST WITH SPUTUM CLEARANCE, BRONCHOSCOPY WAS THEN PERFORMED. UPON INSERTION OF THE BRONCHOSCOPE THROUGH THE ENDOTRACHEAL TUBE, NARROWING OF THE LUMEN WAS OBSERVED AT THE 20 CM MARKING OF THE TUBE. THE ORIGINAL ENDOTRACHEAL TUBE WAS IMMEDIATELY REMOVED, AND RE-INTUBATION WAS PERFORMED WITH ANOTHER ENDOTRACHEAL TUBE.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 25839546 ↗
• MalfunctionJul 16, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 25839338 ↗
• MalfunctionJul 15, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 25830295 ↗
• MalfunctionJul 13, 2026Gas/Air Leak

  Patient problems: Unintended Extubation

  MAUDE report 25804458 ↗
• MalfunctionJul 9, 2026

  PER REPORTING STAFF, AFTER INTUBATION, IT WAS NOTED THAT THE AIR CUFF WAS NOT HOLDING AIR. PATIENT REQUIRED EMERGENT REINTUBATION. TUBE CHANGED OUT USING GLIDESCOPE AND BOUGIE. AT NO TIME WAS THE PATIENT DESATURATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763174 ↗
• MalfunctionJul 7, 2026Use of Device Problem

  IT WAS REPORTED THAT WHILE THE PATIENT WAS ON MECHANICAL VENTILATION VIA THE ENDOTRACHEAL TUBE, THE VENTILATOR ALARMED INDICATING A LEAK IN THE BREATHING CIRCUIT. AFTER CHECKING, THE BREATHING CIRCUIT WAS FOUND TO BE INTACT, AND IT WAS DISCOVERED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD RUPTURED. THE ENDOTRACHEAL TUBE WAS REPLACED, AND VENTILATION RETURNED TO NORMAL.

  Patient problems: Unintended Extubation

  MAUDE report 25732601 ↗
• MalfunctionJun 16, 2026Decoupling

  IT WAS REPORTED THAT DURING USE, THE ORANGE CONNECTOR AT THE END OF THE SUBGLOTTIC SUCTION OF THE ENDOTRACHEAL TUBE WAS FOUND TO BE DETACHED. THIS CAUSED AIR LEAKAGE AND INSUFFICIENT SUCTION PRESSURE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 25527034 ↗
• MalfunctionMay 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT AT THE TIME OF ENDOTRACHEAL TUBE INSERTION, THE CUFF WAS CHECKED AND NO LEAKAGE WAS FOUND, AND THE CUFF PRESSURE WAS WITHIN THE NORMAL RANGE. CUFF LEAKAGE OCCURRED AFTER APPROXIMATELY 30 HOURS OF USE. THE ENDOTRACHEAL TUBE WAS REPLACED, THE PATIENT¿S VITAL SIGNS REMAINED STABLE.

  Patient problems: Unintended Extubation

  MAUDE report 25325399 ↗
• InjuryMay 27, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE AND THEN TRANSFERRED TO THE OPERATING ROOM FOR SURGERY. AFTER THE SURGERY, WHILE MONITORING, A LOW TIDAL VOLUME AND OCCASIONAL AIR LEAKAGE SOUNDS WERE OBSERVED. INITIALLY, THE CUFF WAS INFLATED TO INCREASE PRESSURE, BUT THE EFFECT WAS POOR. THE ENDOTRACHEAL TUBE WAS REPLACED.

  Patient problems: Hypoventilation; Unintended Extubation

  MAUDE report 25302641 ↗
• MalfunctionMay 14, 2026Use of Device Problem

  IT WAS REPORTED THAT IN PREPARATION FOR INTUBATION, THE CUFF OF THE ENDOTRACHEAL TUBE INFLATED TO ENSURE IT WOULD HOLD AIR. CUFF IMMEDIATELY DEFLATE AND WOULD NOT HOLD AIR. ANOTHER ENDOTRACHEAL TUBE WAS CHECKED OUT AND USED FOR THE INTUBATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172362 ↗
• InjuryMay 8, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE ICU POSTOPERATIVELY WITH AN ENDOTRACHEAL TUBE IN PLACE. AFTER TRANSFER, THE CUFF PRESSURE WAS CHECKED AND FOUND TO BE BELOW THE NORMAL RANGE. THE CUFF WAS INFLATED WITH A 5-ML SYRINGE BUT THE CUFF PRESSURE REMAINED LOW. AFTER CONNECTION TO THE VENTILATOR, A LOW TIDAL VOLUME ALARM OCCURRED, AND ABNORMAL AIRWAY NOISE WAS HEARD FROM THE PATIENT¿S THROAT. THE PHYSICIAN WAS NOTIFIED, AND AN ANESTHESIOLOGIST REPLACED THE TUBE. AFTER RE-INTUBATION, THE PATIENT¿S RESPIRATION AND OXYGEN SATURATION RETURNED TO NORMAL. SUBSEQUENT ANALYSIS DETERMINED THAT THE CUFF OF THE REMOVED TUBE WAS DAMAGED, RESULTED INSUFFICIENT CUFF PRESSURE. THE SECOND INTUBATION INCREASED PATIENT'S DISCOMFORT AND ALSO INCREASED THE RISK OF POTENTIAL COMPLICATIONS.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 25125412 ↗
• InjuryApr 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT AT 19:21 ON (B)(6) 2026, THE PATIENT WAS ADMITTED TO THE DEPARTMENT DUE TO ACUTE HEART FAILURE. AT 19:35, THE PATIENT DEVELOPED SIGNIFICANT DYSPNEA. AS PRESCRIBED, PROPOFOL WAS ADMINISTERED INTRAVENOUSLY FOR SEDATION, AND ORAL ENDOTRACHEAL INTUBATION WAS PERFORMED WITH INSERTION DEPTH OF 24 CM. THE PATIENT WAS THEN CONNECTED TO A VENTILATOR FOR ASSISTED VENTILATION. FROM 23:00 ON (B)(6) TO 08:30 ON (B)(6), THE BEDSIDE NURSE CHECKED THE CUFF PRESSURE EVERY TWO HOURS AND FOUND IT TO BE DEFLATED EACH TIME. THE VENTILATOR FREQUENTLY ALARMED, INDICATING INSUFFICIENT VENTILATION AND LOW TIDAL VOLUME FOR A TOTAL OF 8H . DURING THE NIGHT, MULTIPLE ATTEMPTS TO INFLATE THE CUFF USING A CUFF PRESSURE MONITOR FAILED TO DETECT CUFF PRESSURE OR LEAKAGE, AND CUFF DAMAGE WAS SUSPECTED. AT 08:30, THE ANESTHESIOLOGY TEAM ASSISTED AT THE BEDSIDE TO REPLACE THE TUBE. AFTER REPLACEMENT, THE PATIENT¿S OXYGEN SATURATION RETURNED TO NORMAL AND VENTILATOR PARAMETERS STABILIZED. INSPECTION REVEALED THAT THE CUFF OF THE REMOVED TUBE WAS LEAKING AND DAMAGED.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 25023402 ↗
• MalfunctionApr 27, 2026Use of Device Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF DID NOT INFLATE WHEN AIR WAS INTRODUCED THROUGH THE PILOT BALLOON. THE CUFF WAS DESCRIBED AS FEELING RIGID DURING THE ATTEMPTED INFLATION TEST. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009610 ↗
• MalfunctionApr 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE HAD AN AIR LEAK DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24927997 ↗
• MalfunctionApr 16, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE'S CUFF PRESSURE WAS INSUFFICIENT. AFTER INFLATION USING A M ANOMETER, THE CUFF PRESSURE REMAINED INADEQUATE. UPON INSPECTION, A SMALL AMOUNT OF MOISTURE WAS OBSERVED INSIDE THE CUFF, AND CUFF AIR LEAKAGE WAS IDENTIFIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895025 ↗
• MalfunctionApr 8, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION OF THE ENDOTRACHEAL TUBE, THE CUFF LEAKED AIR. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 24815524 ↗