HUDSON RCI IPN048874Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 14026704616531), received between Jan 26, 2021 and Aug 23, 2022 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT.NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274564 ↗
• MalfunctionMay 11, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14356525 ↗
• MalfunctionApr 22, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER 20 MINUTES OF SURGERY, A SUDDEN LEAK OCCURRED. THE ANAESTHETIST THEN PERFORMED A CONTINUOUS "OVER-INFLATION" UNTIL THE END OF THE SURGERY. ( >50MMHG)". ADDITIONAL INFORMATION STATED THAT THE PATIENT'S VENTILATION WAS NOT INTERRUPTED BY THE LEAK. NO MEDICAL INTERVENTION REQUIRED. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190293 ↗
• MalfunctionMar 28, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT AND CHANGED NEW ONE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930705 ↗
• MalfunctionDec 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080534 ↗
• MalfunctionOct 29, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT "THE CUFF DID NOT SEAL THE TRACHEA PROPERLY WITH A CUFF PRESSURE OF 30 MMHG. EVEN AFTER INFLATING THE CUFF TO A PRESSURE OF 60 MMHG THE CUFF STILL DID NOT SEAL THE TRACHEA". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724175 ↗
• MalfunctionOct 29, 2021Inflation Problem; Leak/Splash; Improper Flow or Infusion; Inflation Problem; Leak/Splash; Improper Flow or Infusion

  IT WAS REPORTED THAT "THE CUFF DID NOT SEAL THE TRACHEA PROPERLY WITH A CUFF PRESSURE OF 30 MMHG. EVEN AFTER INFLATING THE CUFF TO A PRESSURE OF 60 MMHG THE CUFF STILL DID NOT SEAL THE TRACHEA". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724025 ↗
• 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 12638909 ↗
• MalfunctionOct 12, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "DURING USE ON THE PATIENT, VENTILATION WAS INSUFFICIENT. THE AIR DID NOT GO INTO THE PATIENT. PATIENT HAD TO BE RE-INTUBATED AND VENTILATED BY HAND. NO PATIENT HARM OCCURRED". UNKNOWN PATIENT CONDITION AT TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617223 ↗
• MalfunctionSep 14, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED "CUFF DEFLATED ON COVID+ PATIENT AND TUBE WAS EXCHANGED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468601 ↗
• InjurySep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CONNECTORS FELL OFF 3 DIFFERENT TUBES WITH 3 DIFFERENT PATIENTS WHILE CONNECTED TO VENTILATOR". THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12441297 ↗
• InjurySep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CONNECTORS FELL OFF 3 DIFFERENT TUBES WITH 3 DIFFERENT PATIENTS WHILE CONNECTED TO VENTILATOR". THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12441245 ↗
• InjurySep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CONNECTORS FELL OFF 3 DIFFERENT TUBES WITH 3 DIFFERENT PATIENTS WHILE CONNECTED TO VENTILATOR". THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12441208 ↗
• MalfunctionSep 8, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "CUFF NOT INFLATING OR STAYING INFLATED. PATIENT WAS IN A ROUTINE OPEN HEART CASE FOR 4 HOURS AND IMMEDIATELY OUT OF THE OR THE TUBE HAD TO BE EXCHANGED DUE TO CUFF NOT HOLDING AIR". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440643 ↗
• MalfunctionAug 20, 2021Gas/Air Leak

  PATIENT WITH HISTORY OF COVID, PNEUMONIA AND HYPOXIA. TELEFLEX HUDSON RCI ENDOTRACHEAL TUBE CUFF TESTED PRIOR TO INTUBATION WITHOUT PROBLEMS. WHILE THE PATIENT WAS INTUBATED, THE CUFF LEAKED AND THE ENDOTRACHEAL TUBE WAS EXCHANGED. ORIGINAL PACKAGING WAS NOT SAVED. THERE HAVE BEEN SEVERAL INCIDENTS WITH TELEFLEX ENDOTRACHEAL TUBES. LISTED BELOW ARE ADDITIONAL INCIDENTS WITH THE DEVICE. THE ENDO TUBE IN REPORT ABOVE WAS NOT AFTER A PROCEDURE. CUFF LEAKED AIR AND TUBE EXCHANGED. INCIDENT REPORTED BUT NO TUBE WAS NOT AFTER A PROCEDURE. CONNECTOR POPPED OFF 2 TIMES. INCIDENT REPORTED BUT NO TUBE WAS AFTER A PROCEDURE. CARDIOVASCULAR SURGERY AND THEN BEING TRANSFERRED. CUFF LOSING AIR AND WAS INTUBATED AT BEDSIDE.

  Patient problems: Insufficient Information

  MAUDE report 12347805 ↗
• MalfunctionAug 5, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE CUFF WAS FOUND LEAKING WHEN USING ON PATIENT". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280897 ↗
• MalfunctionAug 5, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE CUFF WAS FOUND LEAKING WHEN USING ON PATIENT". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280732 ↗
• MalfunctionAug 5, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE CUFF WAS FOUND LEAKING WHEN USING ON PATIENT". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280706 ↗
• MalfunctionAug 5, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE CUFF WAS FOUND LEAKING WHEN USING ON PATIENT". NO PATIENT INJURY, HARM, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280682 ↗
• MalfunctionJan 26, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "ON THE MORNING OF (B)(6) 2021, DURING THE OPERATION, THE CUFF WAS FOUND TO BE LEAKING. AFTER TESTING IT IN THE WATER, THE CUFF WAS REALLY LEAKING. THEREFORE, THE DOCTOR REPLACED WITH NEW ONE AND NO IMPACT ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229567 ↗

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-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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• 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-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-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-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.