HUDSON RCI IPN044767Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04026704397044), received between Dec 14, 2023 and Oct 15, 2025 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "PATIENT HAD BEEN RECENTLY INTUBATED- RESPIRATORY THERAPY NOTED WHAT THEY THOUGHT TO BE A LEAK FROM THE ETT CUFF. PATIENT WAS REINTUBATED BY THE PROVIDER. THIS RN INJECTED AIR INTO ORIGINAL ETT CUFF AND IT WAS VISIBLY DEFLATING, NOT HOLDING AIR AS INTENDED. NO HARM RELATED TO PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301545 ↗
• MalfunctionSep 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT: "ENDOTRACHEAL TUBE HAD AN ISSUE WITH THE HUB COMING LOOSE.". ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093751 ↗
• MalfunctionJul 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: "PATIENT REINTUBATED, WHEN ETT IN PLACE, AIR WAS PUSHED INTO THE CUFF BUT THE CUFF DID NOT INFLATE. ETT HAD TO BE REPLACED. THERE NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468411 ↗
• InjuryJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "BLOWN / DEFLATED CUFF DURING PATIENT USE". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY, "JUST DELAY IN CARE". HOWEVER THE INFORMATION STATES IN REGARDS TO DESATURATION, "I AM SURE THEY DID, ALL PATIENTS [DESATURATE] DURING THIS PROCEDURE". IT IS UNKNOWN WHAT OXYGEN PERCENTAGE THE PATIENT DESATURATED TO. THE ISSUE WAS RESOLVED BY REINTUBATING THE PATIENT. THE CURRENT PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 21274467 ↗
• InjuryJan 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "BLOWN / DEFLATED CUFF DURING PATIENT USE". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY, "JUST DELAY IN CARE". HOWEVER, THE INFORMATION STATES IN REGARD TO DESATURATION, "I AM SURE THEY DID, ALL PATIENTS [DESATURATE] DURING THIS PROCEDURE". IT IS UNKNOWN WHAT OXYGEN PERCENTAGE THE PATIENT DESATURATED TO. THE ISSUE WAS RESOLVED BY REINTUBATING THE PATIENT. THE CURRENT PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 21274419 ↗
• MalfunctionDec 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "DURING TRAUMA LAPAROTOMY, THE PRODUCTS KINKED PROXIMAL TO CUFF AND WERE OBSTRUCTED DURING SURGERY (TOO SOFT). PATIENT CONSEQUENCE HIGH AIRWAY PRESSURES AND THERE WAS 2 ATTEMPTS TO PASS SUCTION CATHETER WITHIN ETT LUMEN, BRONCHOSCOPY ULTIMATELY REQUIRED, INTRA-OP ENT CONSULTATION. THE PATIENT DID NOT DESATURATE."

  Patient problems: Airway Obstruction

  MAUDE report 20851318 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE, "FAILED CUFF SEAL". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833360 ↗
• MalfunctionOct 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "UNION HAD A TELEFLEX FAILURE ISSUE LAST NIGHT AND WAS REPORTED TO SAFETY NET AFTER THE EVENT. THE FAILURE RESULTED IN THE PATIENT HAVING TO BE REINTUBATED.". ADDITIONAL INFORMATION: "THE PATIENT HAD TO BE RE-INTUBATED WHICH CAUSED A DELAY TO TREATMENT BUT THERE WAS NO OTHER HARM OR CONSEQUENCE TO THE PATIENT. THERE WAS NO DESATURATION.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566841 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT: "INTUBATE & TEST OKAY. COULD NOT BUILD UP TIDAL VOLUME AFTER CONNECT VENTILATOR. CHANGED ETT AND FOUND THE CUFF BROKEN". THERE WAS 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 19790523 ↗
• MalfunctionMay 21, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT: "PILOT BALLOON ETT FAILURE. INITIAL FAILURE MAY BE RELATED TO AGITATION AND POSSIBLY PATIENT BITING TUBE." ASSOCIATED COMPLAINTS 3003898360-2024-00494, 30038983 60-2024-00496, 3003898360-2024-00493 AND 3003898360-2024-00495.

  Patient problems: Insufficient Information

  MAUDE report 19360586 ↗
• MalfunctionMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, "PILOT BALLOON ETT FAILURE. INITIAL FAILURE MAY BE RELATED TO AGITATION AND POSSIBLY PATIENT BITING TUBE". ASSOCIATED COMPLAINTS 3003898360-2024-00494, 3003898360-2024-00496, 3003898360-2024-00493 AND 3003898360-2024-00495.

  Patient problems: Insufficient Information

  MAUDE report 19358602 ↗
• MalfunctionMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT: "PILOT BALLOON ETT FAILURE. INITIAL FAILURE MAY BE RELATED TO AGITATION AND POSSIBLY PATIENT BITING TUBE." ASSOCIATED COMPLAINTS 3003898360-2024-00494, 30038983 60-2024-00496 AND 3003898360-2024-00495.

  Patient problems: Insufficient Information

  MAUDE report 19357669 ↗
• MalfunctionMay 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE CUFF LEAKED DURING USE ON PATIENT."

  Patient problems: Insufficient Information

  MAUDE report 19219437 ↗
• MalfunctionMay 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: PATIENT WAS BEING INTUBATED FOR ENDOSCOPY PROCEDURE. CRNA TESTED ETT CUFF PRIOR TO INTUBATION. PATIENT WAS INT UBATED WITHOUT INCIDENT USING RSI BY CRNA WITH RN SUPPORT. CRNA NOTED DIFFICULTY KEEPING CUFF INFLATED. PATIENT WITH STABLE VITAL SIGNS THROUGHOUT. OROGASTRIC TUBE PLACED TEMPORARILY PER DR VERBAL ORDER TO DECOMPRESS STOMACH TO SEE IF ISSUE RESOLVED. 50ML GASTRIC CONTENTS SUCTIONED OUT AND OG TUBE REMOVED. ETT CUFF STILL NOT INFLATING CORRECTLY. DECISION MADE BY ANESTHESIOLOGIST AND CRNA TO REMOVE ETT AND REINTUBATE WITH A NEW TUBE. PATIENT THEN INTUBATED WITHOUT DIFFICULTY AND CUFF INFLATED BY CRNA. DEFECTIVE ETT WAS TESTED IN A GRADUATED CYLINDER OF WATER, AND AN AIR LEAK WAS NOTED AT THE SEAL OF THE CUFF TO THE TUBE. TUBE DISCARDED AFTER DEFECT WAS SHOWN TO ENDO CHARGE RN AND ENDOSCOPY MANAGER.

  Patient problems: Insufficient Information

  MAUDE report 19219304 ↗
• MalfunctionApr 2, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "UNABLE TO INFLATE THE CUFF." THE ISSUE WAS IDENTIFIED PRIOR TO USE ON A PATIENT DURING INSPECTION FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017502 ↗
• MalfunctionMar 29, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "30 MINUTES AFTER THE PATIENT WAS INTUBATED THE NURSE NOTICED THAT THE PILOT BALLON WAS NOT INFLATED, THE CUFF WAS FLAT AND WOULD NOT HOLD AIR. THE PATIENT WAS SUCTION FOR ASPIRATION. IT WAS REPORTED THAT THE PATIENT BEGAN TO DESATURATE, BUT IT WAS NOTICED ON TIME AND THERE WAS NO HARM OR CONSEQUENCE FOR THE PATIENT. THEY WERE DISCHARGED HOME SINCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002266 ↗
• MalfunctionMar 20, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: KINKED TUBE. THE ISSUE WAS IDENTIFIED AFTER OPENING AND WAS NOT USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941178 ↗
• MalfunctionMar 20, 2024Leak/Splash; Leak/Splash

  IT IS REPORTED THAT: CUFFS ARE LEAKING. THIS HAPPENED IN 3 DIFFERENT TUBES. THE TUBES WERE OPENED PRIOR TO USE ON THE PATIENT AND EACH ONE THEY SAW THE CUFF WAS LEAKING. ASSOCIATED COMPLAINTS: 3003898360-2024-00246, 3003898360-2024-00245.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941081 ↗
• MalfunctionMar 20, 2024Leak/Splash; Leak/Splash

  IT IS REPORTED THAT: CUFFS ARE LEAKING. THIS HAPPENED IN 3 DIFFERENT TUBES. THE TUBES WERE OPENED PRIOR TO USE TO ON THE PATIENT AND EACH ONE THEY SAW THE CUFF WAS LEAKING.ASSOCIATED COMPLAINTS: 3003898360-2024-00245 AND 3003898360-2024-00247.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940259 ↗
• MalfunctionMar 15, 2024Leak/Splash; Leak/Splash

  THE 3 TUBES WERE OPENED PRIOR TO USE TO ON THE PATIENT AND EACH ONE THEY SAW THE CUFF WAS LEAKING. ASSOCIATED COMPLAINTS 3003898360-2024-00246 AND 3003898360-2024-00247.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911274 ↗
• InjuryMar 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CLINICIANS AT THE HOSPITAL: "LEAKING FROM ETT TUBES. IT IS TAKING A LOT TO FILL THE BALLOON, THEN THE LEAKING ISSUE ARISES.". ADDITIONAL INFORMATION FROM CLINICIANS: THE PATIENT HAD LOW TIDAL VOLUMES AND SPO2. IT IS UNKNOWN IF THE PATIENT DESATURATED BECAUSE OF THE DEFECT. THE TUBE WAS EXCHANGED, AND PATIENT WAS REINTUBATED. THE PATIENT'S CURRENT CONDITION IS DECEASED. CAUSE OF DEATH WAS REPORTED AS PNA, ARDS, HYPOXIC RESPIRATORY FAILURE. DEATH OCCURRED 3 DAYS AFTER THE REPORTED DEFECT WAS DISCOVERED. THE PATIENTS UNDERLYING HISTORY: ESOPHAGEAL CA.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18893720 ↗
• InjuryMar 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CLINICIANS AT THE HOSPITAL: LEAKING FROM ETT TUBES. IT IS TAKING A LOT TO FILL THE BALLOON, THEN THE LEAKING ISSUE ARISES." ADDITIONAL INFORMATION FROM CLINICIANS: THE PATIENT HAD LOW TIDAL VOLUMES. THE TUBE WAS EXCHANGED, AND PATIENT WAS REINTUBATED. THE PATIENT'S CURRENT CONDITION IS DECEASED. CAUSE OF DEATH SEPTIC SHOCK AND RESPIRATORY FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 18893690 ↗
• InjuryMar 12, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CLINICIANS AT THE HOSPITAL: "LEAKING FROM ETT TUBES. IT IS TAKING A LOT TO FILL THE BALLOON, THEN THE LEAKING ISSUE ARISES." ADDITIONAL INFORMATION FROM CLINICIANS: THE PATIENT HAD LOW TIDAL VOLUMES AND LOW OXYGEN SATURATIONS. THE TUBE WAS EXCHANGED. THE PATIENT'S CURRENT CONDITION IS DECEASED. DEATH OCCURRED 13 HOURS AFTER THE REPORTED ISSUE WAS DISCOVERED. CAUSE OF DEATH WAS REPORTED AS HYPOXIC RESPIRATORY FAILURE, ACUTE RENAL FAILURE, AND HYPERKALEMIA. PATIENTS UNDERLYING HISTORY: CAD S/P CABG, CHRONIC BACK PAIN ON OPIATES, HTN T2DM AND HLD.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18884163 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE 15MM CONNECTORS WERE COMING OFF THE PROXIMAL END OF THE TUBES." ADDITIONAL INFORMATION REPORTS THERE WAS NO PATIENT DESATURATIONS DUE TO THE DISCONNECTION. NO PATIENT HARM OR INJURY. THE PATIENTS CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER 3003898360-2024-00200, 3003898360-2024-00202, AND 3003898360-2024-00136.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681039 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE 15MM CONNECTORS WERE COMING OFF THE PROXIMAL END OF THE TUBES." ADDITIONAL INFORMATION REPORTS THERE WAS NO PATIENT DESATURATIONS DUE TO THE DISCONNECTION. NO PATIENT HARM OR INJURY. THE PATIENTS CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER 3003898360-2024-00200,3003898360-2024-00201, AND 3003898360-2024-00136.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18680559 ↗

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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• 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-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-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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• Z-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• Z-1766-2019 · May 24, 2019 · Terminated
  Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-
• Z-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 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-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

…and 12 more.