HUDSON RCI IPN048897Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 14026704616760), received between Feb 18, 2021 and Mar 14, 2023 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2023Deflation Problem; Deflation Problem

  REPORTED ISSUE: THE CUFF DEFLATED AND THE PATIENT HAD TO BE EXTUBATED AND THEN REINTUBATED. NO INJURY REPORTED.

  Patient problems: Unintended Extubation

  MAUDE report 16539823 ↗
• MalfunctionDec 5, 2022Material Rupture; Material Rupture

  REPORTED ISSUE: THREE TIMES IN THE LAST 10 DAYS I HAVE INTUBATED A PATIENT WITH THE HUDSON/SHERIDAN ETT'S SIZE 8 AND HAVE NOTED THAT THE CUFF DOES NOT HOLD AIR OR IS RUPTURED AND I HAVE HAD TO EXCHANGE THE TUBE.

  Patient problems: Insufficient Information

  MAUDE report 15916153 ↗
• MalfunctionDec 5, 2022Material Rupture; Material Rupture

  REPORTED ISSUE: THREE TIMES IN THE LAST 10 DAYS I HAVE INTUBATED A PATIENT WITH THE HUDSON/SHERIDAN ETT'S SIZE 8 AND HAVE NOTED THAT THE CUFF DOES NOT HOLD AIR OR IS RUPTURED AND I HAVE HAD TO EXCHANGE THE TUBE.

  Patient problems: Insufficient Information

  MAUDE report 15916021 ↗
• MalfunctionDec 5, 2022Material Rupture; Material Rupture

  REPORTED ISSUE: THREE TIMES IN THE LAST 10 DAYS I HAVE INTUBATED A PATIENT WITH THE HUDSON/SHERIDAN ETT'S SIZE 8 AND HAVE NOTED THAT THE CUFF DOES NOT HOLD AIR OR IS RUPTURED AND I HAVE HAD TO EXCHANGE THE TUBE.

  Patient problems: Insufficient Information

  MAUDE report 15915971 ↗
• InjuryFeb 25, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: "INCIDENT HAPPENED ON SUNDAY (B)(6) 2021 AT 6:30 P.M, WITH A COVID PATIENT WITH LOW OXYGEN RESERVE. DURING AN INTUBATION THE CUFF OF THE TUBE WAS DEFECTIVE. THE CUFF DID NOT INFLATE PROPERLY. THE CUFF HAD BEEN TESTED TWICE PRIOR TO INTUBATION. WE HAD TO PERFORM AN EMERGENCY REINTUBATION. THE PATIENT DESATURATE (BELOW 80%)". IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM COVID AND THE PATIENT LATER DECEASED AS A RESULT OF COVID RELATED COMPLICATIONS.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 13600282 ↗
• MalfunctionDec 13, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF DIDN'T INFLATE AND DEFLATE EASILY DURING AN INFLATION TEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12986259 ↗
• MalfunctionDec 13, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "THE CUFF DIDN'T INFLATE AND DEFLATE EASILY DURING AN INFLATION TEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12986057 ↗
• MalfunctionOct 5, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "CUFF OF THE ENDOTRACHEAL TUBE IS LEAKING AND THE CLINICIANS HAVE TO REINTUBATE THE PATIENT". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579937 ↗
• MalfunctionOct 5, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED "CUFF OF THE ENDOTRACHEAL TUBE WAS BLOWN COMPLETELY CAUSING CLINICIANS TO HAVE TO REINTUBATE THE PATIENT". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579881 ↗
• MalfunctionSep 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED "CUFF OF THE ENDOTRACHEAL TUBE WAS COMPLETELY BLOWN AND THE PATIENT HAD TO BE REINTUBATED". NO PATIENT INJURY OR HARM REPORTED. UNKNOWN PATIENT CONDITION AT TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518684 ↗
• InjuryJul 23, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT "PATIENT WAS INTUBATED IN OP WITH STYLET AND SILICONE LUBRICANT. PATIENT JOIN ICU AND MET A REPETITIVE DISCONNECTION OF THE ETT CONNECTOR. USER REPLACE THE CONNECTOR BY ANOTHER ONE (FABRICANT UNKNOWN) AND SOLVE THE ISSUE". NO INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220796 ↗
• MalfunctionJun 25, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WHEN THE TUBE HAS TO STAY IN THE PATIENT FOR A WHILE, THERE IS A CUFF LEAKAGE. CUFF HAS TO BE INFLATED OR REPLACED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Unintended Extubation

  MAUDE report 12068109 ↗
• MalfunctionJun 25, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WHEN THE TUBE HAS TO STAY IN THE PATIENT FOR A WHILE, THERE IS A CUFF LEAKAGE. CUFF HAS TO BE INFLATED OR REPLACED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Unintended Extubation

  MAUDE report 12068081 ↗
• MalfunctionJun 25, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WHEN THE TUBE HAS TO STAY IN THE PATIENT FOR A WHILE, THERE IS A CUFF LEAKAGE. CUFF HAS TO BE INFLATED OR REPLACED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Unintended Extubation

  MAUDE report 12068035 ↗
• MalfunctionFeb 18, 2021Inflation Problem; Inflation Problem

  COMPLAINT FROM MAUDE DATABASE: IT WAS REPORTED "BALLOON FAILED TO INFLATE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION IS UNKNOWN AT TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345872 ↗

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-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-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-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-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-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-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-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-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-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-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-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/

…and 12 more.