HUDSON RCI IPN048896Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 14026704616753), received between May 17, 2021 and Jul 31, 2023 — classified as 2 deaths, 30 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (8 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023

  A POWDER LIKE SUBSTANCE WAS FOUND AT THE TOP OF THE TUBE AFTER OPENING THE STERILE PACKAGE & PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423685 ↗
• MalfunctionApr 18, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE HUB DISCONNECTED. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16763570 ↗
• MalfunctionMar 24, 2023Leak/Splash; Leak/Splash

  REPORTED ISSUE: THE TUBE PASSED THE PRE-TEST, BUT AIR LEAKING ALARM OCCURRED AFTER INTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616167 ↗
• MalfunctionMar 14, 2023Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539685 ↗
• MalfunctionMar 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539649 ↗
• MalfunctionMar 6, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: THE ET TUBE DISCONNECTS.

  Patient problems: Insufficient Information

  MAUDE report 16487409 ↗
• MalfunctionMar 6, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: THE ET TUBE DISCONNECTS.

  Patient problems: Insufficient Information

  MAUDE report 16487361 ↗
• MalfunctionMar 6, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: ET TUBE DISCONNECTS.

  Patient problems: Insufficient Information

  MAUDE report 16487329 ↗
• MalfunctionMar 6, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: THE ET TUBE CUFF DEFLATES.

  Patient problems: Insufficient Information

  MAUDE report 16487170 ↗
• MalfunctionMar 6, 2023Failure to Disconnect; Failure to Disconnect

  REPORTED ISSUE: ET TUBE DISCONNECTS.

  Patient problems: Insufficient Information

  MAUDE report 16486879 ↗
• MalfunctionMar 6, 2023Deflation Problem; Deflation Problem

  REPORTED ISSUE: THE CUFF DEFLATED. THE PATIENT WAS REINTUBATED; THERE WAS NO DESATURATION OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16486765 ↗
• MalfunctionFeb 27, 2023Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE ENDOTRACHEAL TUBE CUFF WOULD NOT HOLD PRESSURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16447130 ↗
• MalfunctionFeb 2, 2023Connection Problem; Connection Problem

  REPORTED EVENT: CONNECTOR OF ETT COULD NOT STAY ON, KEPT POPPING OFF. SO IT HAD TO BE REMOVED AND THE PATIENT WAS REINTUBATED WITH ANOTHER ETT. THIS OCCURRED WITH 2 DIFFERENT PATIENTS ON THE SAME DAY, SAME PROBLEM, SAME SOLUTION TO REINTUBATE. NO INJURY REPORTED. (ASSOCIATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283502 ↗
• MalfunctionFeb 2, 2023Connection Problem; Connection Problem

  REPORTED EVENT: CONNECTOR OF ETT COULD NOT STAY ON, KEPT POPPING OFF. SO IT HAD TO BE REMOVED AND THE PATIENT WAS REINTUBATED WITH ANOTHER ETT. THIS OCCURRED WITH 2 DIFFERENT PATIENTS ON THE SAME DAY, SAME PROBLEM, SAME SOLUTION TO REINTUBATE. NO INJURY REPORTED. (ASSOCIATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283463 ↗
• MalfunctionJan 4, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: THE PATIENT WAS INTUBATED WITH TELEFLEX SHERIDAN 7.5 ETT ON 16 DECEMBER. THE TUBE'S HUB CONNECTOR WAS GETTING DISCONNECTED FROM THE ETT AND HAD TO BE REPLACED. THIS WAS REPORTED BY THE UNIT RESPIRATORY THERAPISTS ALONG WITH SIMILAR CONCERNS WITH THE TELEFLEX SHERIDAN ETTS IN THE PAST. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096473 ↗
• MalfunctionDec 14, 2022Inflation Problem; Inflation Problem

  REPORTED ISSUE: PRIOR TO INTUBATING THE PATIENT THEY NOTICED THERE WAS A LEAK IN THE CUFF AND WERE ABLE TO GRAB A DIFFERENT TUBE. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE IN A CLINICAL SETTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982086 ↗
• MalfunctionDec 12, 2022Inflation Problem; Inflation Problem

  REPORTED ISSUE: DURING CASE WITH PATIENT INTUBATED THEY NOTICED THAT THERE WAS A LEAK IN THE CUFF AND THEY NEEDED TO CHANGE IT OUT FOR ANOTHER TUBE. THERE WAS NO REPORTED INJURY AND THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960178 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED "THE ISSUE IS THAT THE CONNECTOR FROM OUR STANDARD TUBE IS UNCOUPLING ON ITS OWN". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. SPECIFIC INFORMATION REQUESTED TO THE CUSTOMER REGARDING THE EVENT HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 13475711 ↗
• MalfunctionJan 28, 2022Disconnection; Disconnection

  IT WAS REPORTED THE CONNECTOR IS UNCOUPLING ON ITS OWN. NO REPORT OF PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13385141 ↗
• MalfunctionNov 11, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WE JUST HAD ANOTHER ETT CUFF FAIL. IT APPEARS TO HAVE LEAKED AND WAS NOT ABLE TO HOLD AIR". PATIENT CONDITION REPORTED AS "FINE". MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 12800394 ↗
• MalfunctionOct 28, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE NURSE JUST HEARD AIR COMING FROM PATIENT, RT ASSESSED, NOTIFIED THE PROVIDER, TUBE WAS EXCHANGED OUT DUE TO CUFF LEAK". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712358 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ET TUBES HAD RUPTURED CUFFS AND REQUIRED TO BE EXCHANGED. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647232 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ET TUBES HAD RUPTURED CUFFS AND REQUIRED TO BE EXCHANGED. NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647128 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED "PT INTUBATED BY DR. PANCHAL USING GLIDESCOPE AND 8.0 ETT PLACED SECURED AT 26CM LIP. ETT SOUNDED LIKE THERE WAS A LEAK- ADDED 1CC OF AIR, DID NOT CHANGE LEAK. ADVANCED TUBE TO 28 CM AT LIP PER DR. PANCHAL. PT ACHIEVING VOLUMES ON VENT, PT AND SPO2 IMPRICING. LARGE AIR LEAK, VENT LOSING VOLUMES AND PT DESATURATING. BRONCHOSCOPE OBTAINED FOR QUICK LOOK. BOUGIE PLACED AND ETT EXCHANGED 7.5 PLACED. BRONCHOSCOPE INSERTED. ETT SECURED AT 23CM LIP. OLD ETT INSPECTED AND CUFF BLOWN". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646713 ↗
• DeathOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED "PATIENT WAS TRANSFERRED EMERGENTLY TO THE ICU VIA RAPID RESPONSE TEAM AND EMERGENTLY INTUBATED DUE TO SPO2 60% DESPITE MAX BIPAP THERAPY. UPON INTUBATION THE ETT PLACEMENT WAS CONFIRMED WITH BILATERAL AUSCULTATION AND RADIOGRAPH, LOW TIDAL VOLUMES AND EXPIRATORY VOLUMES WERE NOTED WITH SIGNIFICANT CUFF LEAK. CUFF WAS DETERMINED TO BE BLOWN. ETT INSERTED WAS TELEFLEX HUDSON RCI SHERIDAN HVT 7.5MM. PATIENT SUBSEQUENTLY RESPIRATORY ARRESTED REQUIRING ACLS MEASURES AND EXCHANGE OF ETT BY MD WITH ROSC. HOWEVER, SHORTLY AFTER PATIENT SUBSEQUENTLY ARRESTED AGAIN AND DESPITE MEDICAL INTERVENTIONS EXPIRED".

  Patient problems: Low Oxygen Saturation

  MAUDE report 12646675 ↗

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-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-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-2317-2019 · Jul 30, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, REF V5-10114 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-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-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/
• 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-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-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

…and 12 more.