SHERIDAN 5-16037Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14026704941176), received between Dec 11, 2025 and Aug 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50289577 ↗
• MalfunctionAug 17, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50289517 ↗
• MalfunctionJul 1, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE." NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681053 ↗
• MalfunctionApr 16, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. CHANGE NEW TUBE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899111 ↗
• MalfunctionJan 9, 2026Gas/Air Leak

  IT WAS REPORTED THAT: "ON (B)(6) 2025, THE PATIENT REQUIRED RESPIRATORY SUPPORT THERAPY. AFTER A SHER-I-BRONCH ENDOBRONCHIAL TUBE WAS INSERTED AND CONNECTED TO A VENTILATOR, A NOTICEABLE LEAKAGE SOUND WAS DETECTED. UPON INVESTIGATION, A LEAK WAS FOUND AT THE BIFURCATION OF THE DOUBLE-LUMEN TUBE. THE TUBE WAS URGENTLY REPLACED, AND NO FURTHER LEAKAGE WAS OBSERVED. THE PATIENT DID NOT DESATURATE AND WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018528 ↗
• MalfunctionJan 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971875 ↗
• MalfunctionDec 31, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT: (B)(6) 2025, THE PATIENT UNDERWENT THORACOSCOPIC PARTIAL LOBECTOMY. UPON ENTERING THE OPERATING ROOM, THE PATIENT WAS GIVEN OXYGEN, AND ELECTROCARDIOGRAPHIC MONITORING WAS INITIATED. AN INTERNAL JUGULAR VEIN PUNCTURE WAS PERFORMED, AND GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION WAS ADMINISTERED. UNDER THE GUIDANCE OF A BRONCHOSCOPE, A LEFT-SIDED DOUBLE-LUMEN TUBE (SIZE 37#F, 28 CM) WAS INSERTED. DURING CUFF INFLATION, THE BLUE CUFF ON THE BRONCHIAL SIDE INFLATED PROPERLY, BUT THE WHITE CUFF ON THE TRACHEAL SIDE COULD NOT BE INFLATED, SUGGESTING DAMAGE TO THE TRACHEAL CUFF. SUBSEQUENTLY, UNDER BRONCHOSCOPIC GUIDANCE, THE TUBE WAS WITHDRAWN UNTIL THE BLUE CUFF WAS POSITIONED IN THE MAIN BRONCHUS, AND THE SURGERY PROCEEDED. AFTER THE OPERATION, THE TUBE WAS REMOVED, AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932634 ↗
• MalfunctionDec 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "PRIOR TO USE DURING TESTING, FOUND CUFF COULD NOT INFLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776387 ↗