HUDSON RCI IPN044856Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04026704397617), received between Sep 20, 2023 and Nov 5, 2025 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 reports).

2 other recalls cover devices cleared under the same FDA submission (K961977); 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.

• MalfunctionNov 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "DURING THE SURGICAL PROCEDURE FOR THE PATIENT, THE TUBE WAS SUCCESSFUL AND THE VENTILATION OF BOTH LUNGS WAS NORMAL. WHEN PERFORMING SINGLE-LUNG VENTILATION, A BLUE BALLOON CUFF WAS INFLATED, BUT LEAKAGE WAS DETECTED. THROUGHOUT THE OPERATION, MANUAL INFLATION WAS CONTINUOUSLY PERFORMED. THE SURGERY WENT SMOOTHLY. AFTER EXTUBATION, THE EXTERNAL SURFACE OF THE BLUE CUFF WAS FOUND TO BE UNDAMAGED, BUT LEAKAGE OCCURRED AFTER INFLATION". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477066 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  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 23377333 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

  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 22410234 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

  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 22410215 ↗
• MalfunctionJun 10, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174876 ↗
• MalfunctionJun 10, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174835 ↗
• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

  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 22156974 ↗
• InjuryMay 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "AFTER INTUBATION, THERE WAS NO LEAK WITH ONE-LUNG VENTILATION. HOWEVER, AIR LEAKING OCCURRED WHEN TRANSITTED TO TWO-LUNG VENTILATION AFTER 2 HOURS SURGERY. PATIENT'S SATURATION DROPPED, SO DOCTOR CHANGED A TUBE IMMEDIATELY." THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22000629 ↗
• MalfunctionMay 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "THERE WAS A HOLE FOUND IN THE CUFF WHEN IT WAS TESTED PRIOR TO USE ON THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000547 ↗
• MalfunctionApr 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT"(B)(6) 2025, THE DOCTOR FOUND BLUE BALLOON CUFF LEAKAGE WHEN USING ON PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863482 ↗
• MalfunctionApr 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "16 JAN 2025, THE DOCTOR FOUND BLUE BALLOON CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. CHANGE NEW TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760562 ↗
• MalfunctionDec 31, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2024, TUBE WITH DISTORTED ANTERIOR END, COULD NOT BE PLACED PROPERLY INTO THE BRONCHUS, REPLACED WITH ANOTHER DEVICE TO SOLVE THE PROBLEM." THERE WAS NO HARM OR CONSEQUENCE TO THAT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047449 ↗
• MalfunctionNov 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808971 ↗
• MalfunctionOct 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "ON (B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE PRIOR TO USING ON PATIENT. CHANGE NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558758 ↗
• MalfunctionOct 16, 2024Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THAT: "AFTER INTUBATION, THERE WAS A COMPLETE KINK AROUND 23.5CM THAT MADE PATIENT'S AIRWAY PRESSURE RISE AND AFFECTED THE VENTILATION. THE PATIENT DID NOT DESATURATE AND WAS REPORTED AS FINE POST THE INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461058 ↗
• MalfunctionSep 20, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT: "ON (B)(6) 2024, THE TUBE BALLOON WAS FOUND TO BE DAMAGED. NO MORE THAN 15 MINUTES AFTER PLACEMENT IN PATIENT, LEAKAGE OF AIR WAS FOUND. THE DEVICE WAS REPLACED. THERE WAS NO HARM TO THE PATIENT." ASSOCIATED COMPLAINTS 3003898360-2024-01164 AND 3003898360-2024-01163.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265038 ↗
• MalfunctionSep 20, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "(B)(6) 2024, THE TUBE BALLOON WAS FOUND TO BE DAMAGED. NO MORE THAN 15 MINUTES AFTER PLACEMENT IN PATIENT, LEAKAGE OF AIR WAS FOUND. THE DEVICE WAS REPLACED. THERE WAS NO HARM TO THE PATIENT." ASSOCIATED COMPLAINTS 3003898360-2024-01164.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265028 ↗
• MalfunctionApr 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212022 ↗
• MalfunctionApr 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THIS WAS FOUND PRIOR TO USE THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172559 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT: LARYNGEAL MASK '4 IS OPENED AND THE BALLOON IS OBSERVED BROKEN. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451324 ↗
• MalfunctionJan 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: (B)(6) 2023, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451232 ↗
• MalfunctionNov 21, 2023Material Too Soft/Flexible; Material Too Soft/Flexible

  THE REPORT STATES, "STARTED CASE WITH AN LMA SIZE 5. DID A BRONCHOSCOPY, AND THEN SWAPPED THE LMA OUT WITH A 37 FRENCH DOUBLE LUMEN TUBE USING THE GLIDESCOPE. THEY WERE HAVING SOME DIFFICULTY PASSING THE TUBE AND NOTICED THE TUBE GETTING TOO SOFT WHEN IT WAS IN THE MOUTH FOR A SHORT PERIOD OF TIME. ONCE THE STYLET WAS PULLED OUT/REMOVED THEY NOTICED KINKING. THEY REMOVED THIS TUBE AND SUCCESSFULLY PASSED NEW ONE". NO PATIENT HARM OR INJURY OTHER THAN A SORE THROAT. THE PATIENT STATUS IS REPORTED AS "RECOVERED UNEVENTFULLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183246 ↗
• MalfunctionNov 21, 2023Material Too Soft/Flexible; Material Too Soft/Flexible

  THE REPORT STATES, "STARTED CASE WITH AN LMA SIZE 5. DID A BRONCHOSCOPY, AND THEN SWAPPED THE LMA OUT WITH A 37 FRENCH DOUBLE LUMEN TUBE USING THE GLIDESCOPE. THEY WERE HAVING SOME DIFFICULTY PASSING THE TUBE AND NOTICED THE TUBE GETTING TOO SOFT WHEN IT WAS IN THE MOUTH FOR A SHORT PERIOD OF TIME. ONCE THE STYLET WAS PULLED OUT/REMOVED THEY NOTICED KINKING. THEY REMOVED THIS TUBE AND SUCCESSFULLY PASSED NEW ONE". NO PATIENT HARM OR INJURY OTHER THAN A SORE THROAT. THE PATIENT STATUS IS REPORTED AS "RECOVERED UNEVENTFULLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183195 ↗
• MalfunctionNov 21, 2023Material Too Soft/Flexible; Material Too Soft/Flexible

  THE REPORT STATES, "STARTED CASE WITH AN LMA SIZE 5. DID A BRONCHOSCOPY, AND THEN SWAPPED THE LMA OUT WITH A 37 FRENCH DOUBLE LUMEN TUBE USING THE GLIDESCOPE. THEY WERE HAVING SOME DIFFICULTY PASSING THE TUBE AND NOTICED THE TUBE GETTING TOO SOFT WHEN IT WAS IN THE MOUTH FOR A SHORT PERIOD OF TIME. ONCE THE STYLET WAS PULLED OUT/REMOVED THEY NOTICED KINKING. THEY REMOVED THIS TUBE AND SUCCESSFULLY PASSED NEW ONE". NO PATIENT HARM OR INJURY OTHER THAN A SORE THROAT. THE PATIENT STATUS IS REPORTED AS "RECOVERED UNEVENTFULLY".

  Patient problems: Pain

  MAUDE report 18182983 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BROKEN WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT. INVOLVED 3 PCS AND 1 PATIENT." NO PATIENT INVOLVEMENT. SEE ASSOCIATED MDRS #3003898360-2023-01511, 3003898360-2 023-01503

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103619 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961977. One submission often covers many models, so check the product and lot details in each record.

• Z-2367-2015 · Jun 1, 2015 · Terminated
  HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bron
• Z-0125-2007 · Sep 27, 2006 · Terminated
  Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bro