HUDSON RCI IPN044732Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04026704396825), received between Sep 7, 2023 and May 7, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

27 other recalls cover devices cleared under the same FDA submission (K822082); 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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Product Quality Problem

  IT WAS REPORTED THAT "STAFF HAS REPORTED THAT THE BALLOONS HAVE FAILED AFTER INTUBATION, REQUIRING RE-INTUBATION WITH NEW ET TUBES. IN ONE CASE, THIS OCCURRED TWICE WITH THE SAME PATIENT, AND IN ANOTHER CASE, IT OCCURRED ONCE." ADDITIONAL INFORMATION RECEIVED ON APRIL 14, 2026, INDICATED THAT "TWO ET TUBES WERE INVOLVED, AND A TOTAL OF TWO PATIENTS WERE INVOLVED. THE DEFECT WAS NOTICED IMMEDIATELY AFTER INTUBATION. NO HARM TO THE PATIENT, BUT MEDICAL INTERVENTION WAS REQUIRED; A BOUGIE WAS USED TO RE-INTUBATE. THE CURRENT CONDITION OF THE PATIENTS IS STABLE. DEVICES WERE PRE-TESTED PER THE IFU." ASSOCIATED MDRS: 3003898360-2026-00219.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119504 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "PATIENT'S ENDOTRACHEAL TUBE (ETT)- INITIAL TUBE REQUIRED REPLACEMENT DUE TO A CUFF FAILURE, A SIGNIFICANT CUFF LEAK WAS OBSERVED. THE PATIENT WAS UNABLE TO RETAIN DELIVERED PRESSURES, INDICATING A FAILURE OF THE CUFF SEAL. INITIAL TROUBLESHOOTING INVOLVED REPLACING THE PILOT BALLOON USING A REPAIR KIT; HOWEVER, THE LEAK PERSISTED. CONSEQUENTLY, THE ETT WAS EXCHANGED FOR ANOTHER SIZE 8.0 TUBE USING A BOUGIE TUBE EXCHANGER. THE REPLACEMENT TUBE WAS PRE-TESTED WITH AIR INFLATION TO CONFIRM CUFF INTEGRITY PRIOR TO PLACEMENT. DESPITE THIS, WITHIN MINUTES OF INTUBATION, THE SECOND TUBE ALSO EXHIBITED A CUFF LEAK, NECESSITATING ANOTHER EXCHANGE USING THE SAME METHOD. BOTH TUBES WERE FROM THE SAME BATCH NUMBER. THE DEFECT WAS IDENTIFIED SHORTLY AFTER INTUBATION; THE FOLLOWING TUBE WAS SUCCESSFUL. MEDICAL INTERVENTION WAS REQUIRED, BUT NO LASTING HARM OR HEALTH CONSEQUENCES WERE OBSERVED. THE PATIENT WAS STABLE THROUGHOUT THE EVENT WHILE RECEIVING APPROPRIATE RESPIRATORY SUPPORT." ASSOCIATED COMPLAINTS . AND 3003898360-2025-00879.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602937 ↗
• MalfunctionNov 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "PATIENT'S ENDOTRACHEAL TUBE (ETT)- INITIAL TUBE REQUIRED REPLACEMENT DUE TO A CUFF FAILURE, A SIGNIFICANT CUFF LEAK WAS OBSERVED. THE PATIENT WAS UNABLE TO RETAIN DELIVERED PRESSURES, INDICATING A FAILURE OF THE CUFF SEAL. INITIAL TROUBLESHOOTING INVOLVED REPLACING THE PILOT BALLOON USING A REPAIR KIT; HOWEVER, THE LEAK PERSISTED. CONSEQUENTLY, THE ETT WAS EXCHANGED FOR ANOTHER SIZE 8.0 TUBE USING A BOUGIE TUBE EXCHANGER. THE REPLACEMENT TUBE WAS PRE-TESTED WITH AIR INFLATION TO CONFIRM CUFF INTEGRITY PRIOR TO PLACEMENT. DESPITE THIS, WITHIN MINUTES OF INTUBATION, THE SECOND TUBE ALSO EXHIBITED A CUFF LEAK, NECESSITATING ANOTHER EXCHANGE USING THE SAME METHOD. BOTH TUBES WERE FROM THE SAME BATCH NUMBER. THE DEFECT WAS IDENTIFIED SHORTLY AFTER INTUBATION; THE FOLLOWING TUBE WAS SUCCESSFUL. MEDICAL INTERVENTION WAS REQUIRED, BUT NO LASTING HARM OR HEALTH CONSEQUENCES WERE OBSERVED. THE PATIENT WAS STABLE THROUGHOUT THE EVENT WHILE RECEIVING APPROPRIATE RESPIRATORY SUPPORT." ASSOCIATED COMPLAINTS 3003898360-2025-00878 AND 3003898360-2025-00879.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602928 ↗
• MalfunctionAug 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "AIR LEAKED FROM THE CUFF DURING THE INFLATION TEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724663 ↗
• MalfunctionJul 23, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT: "CUFF WOULD NOT STAY INFLATED AFTER INTUBATION. EACH CUFF WAS INFLATED PRIOR TO INTUBATION TO TEST. ASSOCIATED COMPLAINTS 3003898360-2025-00571, 3003898360-2025-00598.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574186 ↗
• MalfunctionJul 23, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT: "CUFF WOULD NOT STAY INFLATED AFTER INTUBATION. EACH CUFF WAS INFLATED PRIOR TO INTUBATION TO TEST. ASSOCIATED COMPLAINTS 3003898360-2025-00597 AND 3003898360-2025-00598.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574183 ↗
• MalfunctionJul 23, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT: "CUFF WOULD NOT STAY INFLATED AFTER INTUBATION. EACH CUFF WAS INFLATED PRIOR TO INTUBATION TO TEST. ASSOCIATED COMPLAINTS 3003898360-2025-00571, 3003898360-2025-00597.

  Patient problems: Insufficient Information

  MAUDE report 22574176 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413127 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413073 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412387 ↗
• MalfunctionJun 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "8 MAY 2025, WHEN TUBE WAS INSERTED, THERE WAS A QUALITY PROBLEM WITH THE SUCTION BALLOON. AFTER THE GAS WAS INJECTED, THE BALLOON WAS FILLED BUT THEN THE BALLOON COLLAPSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141885 ↗
• MalfunctionApr 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT"(B)(6) 2025, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889442 ↗
• MalfunctionMar 26, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695518 ↗
• MalfunctionMar 14, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT: "I JUST WANTED TO INFORM YOU OF AN ISSUE THAT WE HAVE BEEN SEEING WITH THE 8.0 MURPHY EYE TUBE. PER ANESTHESIA DOCTORS AND CRNA'S THE BALLOON ON THIS TUBE WILL NOT INFLATE. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED." THERE WERE 10 DEVICES INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 21603477 ↗
• MalfunctionMar 12, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT: "I JUST WANTED TO INFORM YOU OF AN ISSUE THAT WE HAVE BEEN SEEING WITH THE 8.0 MURPHY EYE TUBE. PER ANESTHESIA DOCTORS AND CRNA'S THE BALLOON ON THIS TUBE WILL NOT INFLATE. THINKING IT WAS JUST A BAD TUBE WE OPENED ANOTHER ONE AND IT WAS THE SAME ISSUE. THERE WAS NO HARM OR INJURY TO THE PATIENT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582150 ↗
• MalfunctionSep 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, SLOW LEAKS OCCURRED INTERMITTENTLY AFTER TRACHEAL INSERTION, AND MASSIVE BAG LEAKS OCCURRED ON DAY 3 OF INSERTION." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333750 ↗
• InjurySep 11, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "OVER THE LAST WEEK, I HAVE HAD THREE COMPLAINTS REGARDING ENDOTRACHEAL TUBES. IT WAS THE ON THE TWO FOLLOWING PRODUCTS. THE ISSUE IS THAT THE PILOT BALLOON AND CUFF BOTH INFLATE WELL WHILE TESTING BEFORE INTUBATION. ONCE INTUBATED THE PILOT BALLOON DEFLATES, CAUSING NEGATIVE PRESSURE. THE PATIENT'S OXYGEN SATURATION DROPPED CAUSING THE PHYSICIAN TO EXTUBATE AND REINTUBATE WITH A NEW ET TUBE. THE THERAPIST STATED THE PILOT BALLOON LOSES AIR AND CREATES A NEGATIVE PRESSURE DEFLATING THE CUFF. THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT." ASSOCIATED COMPLAINT 3003898360-2024-01126.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20189337 ↗
• MalfunctionMay 8, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED "AN INCIDENT OCCURRED YESTERDAY WITH AN 8.0 ETT THAT WOULD NOT HOLD AIR IN THE PILOT BALLOON." 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 19267896 ↗
• MalfunctionMay 7, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "ETT TUBE DID NOT INFLATE DURING PROCEDURE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. A NEW ENDOTRACHEAL TUBE WAS PLACED. THE PATIENT'S CONDITION WAS REPORTEDLY "STABLE BEFORE AND AFTER EQUIPMENT MALFUNCTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260390 ↗
• MalfunctionSep 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING USE ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712100 ↗
• InjurySep 7, 2023Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  THE REPORT STATES, "ETT CUFF'S NOT HOLDING AIR. THE ISSUE WAS RESOLVED BY INTUBATING THE PATIENT WITH A NEW ETT. THE PATIENT CURRENT CONDITION WAS REPORTED AS 'DECEASED'". ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT'S UNDERLYING MEDICAL CONDITION WAS REPORTED AS "CRITICAL" WITH PAST MEDICAL HISTORY INCLUDING "ASPIRATION PNEUMONIA DUE TO GASTRIC SECRETIONS, BASAL GANGLION HEMORRHAGIC STROKE WITH THALAMIC ISCHEMIC STROKES". THE CAUSE OF DEATH IS REPORTED AS "PULSELESS ELECTRICAL ACTIVITY, CARDIAC ARREST". THE PATIENT WAS INITIALLY INTUBATED ON AN INPATIENT MEDICAL/SURGICAL FLOOR. THE DEFECT WAS NOTICED AFTER INTUBATION AND THE PATIENT EXPERIENCED A "SLIGHT" DESATURATION TO 91% SP02. THE PATIENT EXPIRED 5 HOURS AFTER THE EVENT. THE PHYSICIAN DID NOT DECLARE THAT THE FAILURE OF THE ETT CUFF TO HOLD AIR CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17698624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K822082. One submission often covers many models, so check the product and lot details in each record.

• Z-2316-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm,
• Z-2315-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g)
• Z-2318-2019 · Jul 30, 2019 · Terminated
  Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
• Z-2312-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10
• Z-2311-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
• Z-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• Z-2314-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009,
• Z-2313-2019 · Jul 30, 2019 · Terminated
  Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0
• Z-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1763-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/
• Z-1764-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0
• Z-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• Z-1762-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-222
• Z-1761-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-2
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management

…and 12 more.