HUDSON RCI IPN048872Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 14026704616517), received between Aug 26, 2021 and Jun 27, 2023 — classified as 1 death, 9 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOON DID NOT INFLATE PROPERLY". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17213209 ↗
• MalfunctionApr 3, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT"THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT. INVOLVED 1 PC".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665654 ↗
• MalfunctionJan 20, 2023Connection Problem; Connection Problem

  REPORTED EVENT: THE PATIENT'S ET TUBE BECAME DISCONNECTED OR CAME APART WHERE THE TUBE CONNECTS TO THE 15 MM CONNECTOR WHILE AN MRI WAS BEING PERFORMED. THE PATIENT WAS EXTUBATED AND AFTER A FEW MORE DAYS IN THE HOSPITAL WAS DISCHARGED TO HOME. (ASSOCIATED REPORT #3003898360-2023-00015).

  Patient problems: Insufficient Information

  MAUDE report 16215416 ↗
• DeathJan 20, 2023Connection Problem; Connection Problem

  REPORTED EVENT: ALL OF THE FOLLOWING WAS REPORTED BY THE CUSTOMER REPRESENTATIVE. DURING USE, A PATIENT'S ET TUBE BECAME DISCONNECTED WHERE THE TUBE CONNECTS TO THE 15 MM CONNECTOR. THE PATIENT CODED. THE PATIENT HAD A HISTORY OF COPD AND CHF AND PRESENTED IN THE EMERGENCY DEPARTMENT VIA EMS ON (B)(6) DUE TO SHORTNESS OF BREATH. THE PATIENT DID NOT HAVE AN ET TUBE ON ARRIVAL TO THE EMERGENCY DEPARTMENT. THE ET TUBE WAS FOUND DISCONNECTED AT THE CONNECTION POINT ON THE ET TUBE AT APPROXIMATELY 1354. AT THIS POINT THE PATIENT WAS MOVING HIS HEAD BACK AND FORTH AND THE OXYGEN SATURATION HAD DROPPED. THE VENTILATOR WAS ALARMING. THE ICU TEAM ARRIVED AT BEDSIDE AND THE PATIENT DEVELOPED CARDIAC ARREST WITH PEA. AS PER ACLS PROTOCOL, THE PATIENT RECEIVED TWO ROUNDS OF CPR AND TWO ROUNDS OF EPINEPHRINE AND SUBSEQUENTLY ACHIEVED ROSC. THE RHYTHM WAS NOTED TO BE ATRIAL FIBRILLATION WITH HEART RATE BETWEEN 90-100 BEATS/MIN. THE PATIENT SUBSEQUENTLY DEVELOPED SHOCK FOR WHICH THE PATIENT WAS ADMINISTERED PRESSOR SUPPORT WITH LEVOPHED, VASOPRESSIN AND STRESS DOSAGE STEROIDS. THE FAMILY WAS UPDATED AT THE BEDSIDE AND THE CODE STATUS UPDATED TO NO CPR. THE PATIENT WAS TERMINALLY EXTUBATED ON (B)(

  Patient problems: Cardiac Arrest; Respiratory Arrest

  MAUDE report 16215362 ↗
• MalfunctionDec 20, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE CUFF WAS DEFORMED AND CAUSED OCCLUSION WHEN DOING CLINICALS BEFORE USING ON A PATIENT. A NEW DEVICE WAS USED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015429 ↗
• MalfunctionNov 4, 2022Leak/Splash; Leak/Splash

  THE INFORMATION STATES THAT THE CLINICIAN TESTED THE CUFF PRIOR TO INTUBATION, AND IT INFLATED NORMALLY. ONCE THEY INTUBATED THE PATIENT, THE CUFF DEFLATED. THE CLINICIAN HAD TO ADD 60-70MMHG TO INFLATE THE CUFF WHICH COULD POTENTIALLY HARM THE PATIENT. THE CUSTOMER CONFIRMED "THE PATIENT WAS DOING PERFECTLY FINE, AND THE DEVICE DID NOT HARM THE PATIENT IN ANY WAY". THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736734 ↗
• MalfunctionOct 15, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE CUFF DEFLATED WHEN PATIENTS WERE POSITIONED IN PRONE POSITION. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638964 ↗
• MalfunctionSep 23, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "DURING THE USE OF THESE ET TUBES, THE USERS OBSERVED LEAKS, REQUIRING AN "OVER-INFLATION" OF THE CUFF OVER 30CM H2O. MONITERED WITH THE MANOMETER". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519040 ↗
• MalfunctionSep 23, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "DURING THE USE OF THESE ET TUBES, THE USERS OBSERVED LEAKS, REQUIRING AN "OVER-INFLATION" OF THE CUFF OVER 30CM H2O. MONITERED WITH THE MANOMETER". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518903 ↗
• MalfunctionAug 26, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED "THE STAFF REPORTED THAT THE CUFF OF THE ET TUBE DEFLATED DURING USE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12373834 ↗

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-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-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-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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
• 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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• 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-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-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-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-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

…and 12 more.