HUDSON RCI IPN044768Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04026704397051), received between Sep 20, 2023 and Jul 15, 2025 — classified as 4 injuries, 13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "ETT PASSED TEST AND BLEW INSIDE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505595 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "CUFF IS BLOWING OUT." ADDITIONAL INFORMATION RECEIVED ON 15APR2025: IT IS MY UNDERSTANDING FROM MY FRONT-LINE STAFF THAT WE HAVE EXPERIENCED AT LEAST THREE OF THESE ENDOTRACHEAL TUBES FAILING WHILE IN USE ON A PATIENT IN OUR ICU. THE FAILURES THAT HAVE TAKEN PLACE HAVE OCCURRED ON THREE SEPARATE PATIENTS. ASSOCIATED COMPLAINTS 3003898360-2025-00407, 3003898360-2025-00408, AND 3003898360-2025-00365.

  Patient problems: Insufficient Information

  MAUDE report 21934437 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "CUFF IS BLOWING OUT." ADDITIONAL INFORMATION RECEIVED ON 15APR2025: IT IS MY UNDERSTANDING FROM MY FRONT-LINE STAFF THAT WE HAVE EXPERIENCED AT LEAST THREE OF THESE ENDOTRACHEAL TUBES FAILING WHILE IN USE ON A PATIENT IN OUR ICU. THE FAILURES THAT HAVE TAKEN PLACE HAVE OCCURRED ON THREE SEPARATE PATIENTS. ASSOCIATED COMPLAINTS 3003898360-2025-00407, 3003898360-2025-00409 AND 3003898360-2025-00365.

  Patient problems: Insufficient Information

  MAUDE report 21934395 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "CUFF IS BLOWING OUT." ADDITIONAL INFORMATION RECEIVED ON 15APR2025: IT IS MY UNDERSTANDING FROM MY FRONT-LINE STAFF THAT WE HAVE EXPERIENCED AT LEAST THREE OF THESE ENDOTRACHEAL TUBES FAILING WHILE IN USE ON A PATIENT IN OUR ICU. THE FAILURES THAT HAVE TAKEN PLACE HAVE OCCURRED ON THREE SEPARATE PATIENTS. ASSOCIATED COMPLAINTS 3003898360-2025-00408, 3003898360-2025-00409 AND 3003898360-2025-00365.

  Patient problems: Insufficient Information

  MAUDE report 21934370 ↗
• MalfunctionApr 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "CUFF IS BLOWING OUT." ADDITIONAL INFORMATION RECEIVED ON 15APR2025: IT IS MY UNDERSTANDING FROM MY FRONT-LINE STAFF THAT WE HAVE EXPERIENCED AT LEAST THREE OF THESE ENDOTRACHEAL TUBES FAILING WHILE IN USE ON A PATIENT IN OUR ICU. THE FAILURES THAT HAVE TAKEN PLACE HAVE OCCURRED ON THREE SEPARATE PATIENTS. THE LAST INCIDENT I PERSONALLY INSPECTED THE ETT WHICH HAD A LEAK IN THE MIDDLE OF THE CUFF WALL. THIS PATIENT HAD BEEN INTUBATED FOR APPROXIMATELY 48 HOURS WITH THIS TUBE BEFORE IT FAILED. ASSOCIATED COMPLAINTS 3003898360-2025-00407, 3003898360-2025-00408, 3003898360-2025-00409.

  Patient problems: Insufficient Information

  MAUDE report 21933650 ↗
• MalfunctionApr 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "ETT HAD LEAK DESPITE APPROPRIATE TROUBLE SHOOTING. NOTED PILOT BALLOON DEFLATING ON ITS OWN. PATIENT REQUIRED RE-INTUBATION WITH DIFFERENT ENT TUBE. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21804034 ↗
• MalfunctionSep 27, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "ETT LEAK". THE LEAK WAS NOT DETECTED DURING THE INTUBATION, BUT AFTER. THE PATIENT WAS RE-INTUBATED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319413 ↗
• InjuryMay 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, 3003898360-2024-00493 AND 3003898360-2024-00495.

  Patient problems: Hypoxia; Insufficient Information

  MAUDE report 19357707 ↗
• 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 19357690 ↗
• MalfunctionMay 9, 2024Disconnection; Material Separation; Disconnection; Material Separation

  IT IS REPORTED THAT: "PATIENT WAS INTUBATED WITH THE ET TUBE. NO DIFFICULTIES DURING THE INTUBATION. SHORTLY AFTER PATIENT WAS INTUBATED THE HUB DISCONNECTED FROM THE ETT SEVERAL TIMES. PATIENT WAS SCHEDULED FOR TRANSPORT AND HUB DISCONNECTED DURING THAT TIME. HUB WAS TAPED TO HELP PREVENT FURTHER DISCONNECTIONS. NO HARM REACHED PATIENT DUE TO RN AND RT AT BEDSIDE. HUB IS CURRENTLY HAVING TO BE SECURED WITH TAPE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19275727 ↗
• InjuryApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "PATIENT WAS INTUBATED VIA THE SCOPE WITH THE TELEFLEX ET TUBE. NO DIFFICULTIES DURING THE INTUBATION. SHORTLY AFTER PATIENT WAS INTUBATED THE HUB CAME DISCONNECTED FROM THE ETT SEVERAL TIMES. PATIENT WAS SCHEDULED FOR TRANSPORT AND HUB CAME DISCONNECTED DURING THAT TIME. HUB WAS TAPED TO HELP PREVENT FURTHER DISCONNECTIONS. NO HARM REACHED PATIENT DUE TO RN AND RT AT BEDSIDE. HUB IS CURRENTLY HAVING TO BE SECURED WITH TAPE." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINT 3003898360-2024-00448.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19212355 ↗
• 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: THE PATIENT DESATURATED AS A RESULT OF THE DEFECT. IT IS UNKNOWN WHAT THE PERCENTAGE WAS. THEY WERE REINTUBATED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18894002 ↗
• 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 SEPSIS WITH SHOCK AND CARDIAC ARREST. DEATH OCCURRED 3 HOURS AFTER THE REPORTED DEFECT WAS IDENTIFIED. PATIENTS UNDERLYING HISTORY: HTN, MYELOFIBROSIS, CHRONIC THROMBOCYTOPENIA, TEMPORAL ARTHRITIS ON LONG TERM STEROIDS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18893731 ↗
• MalfunctionMar 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: WE HAVE HAD SEVERAL ET TUBES WHERE THE PATIENT ET TUBE BECAME SEPARATED MUTILPLE TIMES DURING A SHIFT. THE VENTILATOR ADAPTER REMAINED ATTACHED TO THE VENTILATOR CIRCUIT AND THE PLIABLE PORTION OF THE TUBE BECAME DISCONNECTED FOR THE ADAPTER (HUB). THE PATIENTS WERE REPORTED TO BE "OK". WHEN THE TUBE DISCONNECTED, THE ALARM WENT OFF AND THE STAFF INTERVENED AND PUT THEM BACK ON VENTILATION. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18814669 ↗
• MalfunctionJan 26, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: ON (B)(6) 2023, DR HAD TWO OTTS FAIL THE CUFF CHECK PRIOR TO AN INTUBATION. DEVICE WAS NOT USED ON PATIENT AND THERE WAS NO REPORTS OF HARM/ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589988 ↗
• MalfunctionJan 18, 2024Material Integrity Problem; Material Integrity Problem

  ON (B)(6). DR HAD TWO ET TUBES FAIL THE CUFF CHECK PRIOR TO AN INTUBATION. DEVICE WAS NOT USED ON PATIENT OR ANY REPORTS OF HARM/ADVERSE EVENTS. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE (IN A CLINICAL SETTING). THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED TO ANOTHER COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534817 ↗
• MalfunctionSep 20, 2023Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT PRIOR TO USE IN THE CLINICAL SETTING, "THE CUFF ON THE ENDOTRACHEAL TUBE ARE DIFFICULT TO INFLATE AND DO NOT HOLD AIR/PRESSURE WELL AND ARE VERY PRONE TO LEAKS. [THEY] DO NOT WORK DURING SURGICAL CASES REQUIRING TRENDELENBURG WITH INCREASE IN ABDOMINAL PRESSURE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783033 ↗

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-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-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-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-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-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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• 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-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
• Z-1760-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm,
• 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-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

…and 12 more.