HUDSON RCI IPN046760Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04026704588794), received between Aug 29, 2019 and Feb 20, 2026 — classified as 1 death, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT "HAD ISSUES WITH TWO ETTS. FIRST THEY HEARD LEAK WHEN INTUBATING THE PATIENT AND HAD TO USE A DIFFERENT TUBE. THE NEXT THEY CHECKED THE TUBES PRESSURE PRIOR TO INTUBATION AND NOTICED A LEAK IN THE CUFF". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400537 ↗
• MalfunctionDec 15, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT: "I INFLATED THE BALLOON AND DID A QUICK SQUEEZE PRIOR TO INTUBATION, AND IT SEEMED TO HOLD AIR. HOWEVER, I QUICKLY DEFLATED THE BALLOON SO PERHAPS I DIDN'T LEAVE THE BALLOON INFLATED LONG ENOUGH TO ENSURE IT WOULD STAY INFLATED ONCE PLACED. ANOTHER POSSIBILITY IS THAT THE BALLOON WAS WORKING BUT IT GOT PUNCTURED BY A TOOTH ON INSERTION, ALTHOUGH IT WAS A PRETTY SMOOTH INSERTION SO I'M NOT SURE THAT WAS THE CASE. THE CONNECTOR WAS FIRMLY ATTACHED AND THERE WAS NO DETACHMENT AS IT WAS AN ISSUE WITH THE ETT CUFF NOT HOLDING AIR. THE PATIENT HAD POOR RESERVE FROM RESPIRATORY FAILURE DUE TO DECOMPENSATED HEART FAILURE AND WAS REQUIRING 15L NRB WITH SPO2 ONLY 88-89% PRIOR TO INTUBATION. HIS SPO2 MAINTAINED 93-95 DURING BVM VIA ETT AND HIS TUBE WAS EXCHANGED WITHOUT ISSUE PRIOR TO HOOKING HIM UP TO THE VENT AS THE DEFLATED CUFF WAS NOTICED IMMEDIATELY AFTER THE ETT WAS INSERTED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803395 ↗
• MalfunctionSep 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "PATIENT WAS INTUBATED WITHOUT ANY DIFFICULTY. PRIOR TO INTUBATION, ET TUBE WAS CHECKED AND THE CUFF WAS WORKING. HOWEVER, SHORTLY AFTER INTUBATION, PATIENT STARTED TO HAVE LEAK. BALLOON ATTACHED TO THE CUFF SHOWED LOW PRESSURE. WE TRIED TO PUT AIR IN IT BUT LEAK PERSISTED. WE HAD TO TAKE THIS TUBE OUT AND PUT A NEW TUBE IN. THIS ONE WENT WITHOUT ANY DIFFICULTY AS WELL. THIS TIME WE DID NOT HAVE ANY PROBLEM WITH THE CUFF LEAK. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093680 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "NOTIFIED BY RT MANAGER MONSUR THAT ED EXPERIENCED A BLOWN CUFF ON SIZE 8 SHERIDAN ETT REQUIRING EXTUBATION AND ETT EXCHANGE." THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017712 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "NOTIFIED BY RT MANAGER MONSUR THAT ED EXPERIENCED A BLOWN CUFF ON SIZE 8 SHERIDAN ETT REQUIRING EXTUBATION AND ETT EXCHANGE." THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015440 ↗
• MalfunctionAug 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "NOTIFIED BY RT MANAGER MONSUR THAT ED EXPERIENCED A BLOWN CUFF ON SIZE 8 SHERIDAN ETT REQUIRING EXTUBATION AND ETT EXCHANGE." THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007439 ↗
• MalfunctionAug 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "NOTIFIED BY RT MANAGER MONSUR THAT ED EXPERIENCED A BLOWN CUFF ON SIZE 8 SHERIDAN ETT REQUIRING EXTUBATION AND ETT EXCHANGE." THE PATIENT WAS REINTUBATED. THERE WAS NO PATIENT HARM. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004225 ↗
• MalfunctionAug 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT "ED EXPERIENCED A BLOWN CUFF ON SIZE 8 SHERIDAN ETT REQUIRING EXTUBATION AND ETT EXCHANGE. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS 'FINE' POST-PROCEDURE". ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT DID NOT DESATURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992922 ↗
• DeathNov 24, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE CUFF ON THIS TUBE BLEW AS SOON AS THE PATIENT WAS INTUBATED, UNABLE TO KEEP AIR IN THE CUFF IMMEDIATELY AFTER INTUBATION". IT WAS REPORTED THAT THE PATIENT WAS DECEASED. IT WAS REPORTED THAT THE DEVICE WAS NOT CONTRIBUTORY TO THE PATIENT DEATH.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12868298 ↗
• MalfunctionAug 29, 2019Disconnection

  THE PATIENT WAS INTUBATED THAT MORNING AND THE ET TUBE KEPT DISCONNECTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8944430 ↗

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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 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-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-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-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-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-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-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• 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-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-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-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management

…and 12 more.