HUDSON RCI IPN048895Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 14026704616746), received between Apr 16, 2021 and Feb 27, 2023 — classified as 1 death, 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE ENDOTRACHEAL TUBE CUFF WOULD NOT HOLD AIR AND THE 7.0 SIZE WOULD NOT HOLD PRESSURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16446715 ↗
• MalfunctionFeb 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED ISSUE: THE HUB KEPT POPPING OFF ON AN INTUBATED PATIENT ON A VENTILATOR. NO INFORMATION PROVIDED FOR THE PATIENT'S CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 16410023 ↗
• MalfunctionFeb 8, 2023Deflation Problem; Deflation Problem

  REPORTED EVENT: THE CUFF COULD NOT BE DEFLATED COMPLETELY DURING INSPECTION PRIOR TO USE.

  Patient problems: Insufficient Information

  MAUDE report 16324581 ↗
• InjuryDec 30, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTED ISSUE: WHILE INTUBATING THE PATIENT THE STYLET WOULD NOT COME OUT; TWO PEOPLE TRIED. THIS ETT WAS REMOVED AND THE PATIENT WAS REINTUBATE WITH THE COVIDIEN ETT FROM WHICH THE STYLET WAS REMOVED WITH NO PROBLEM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078379 ↗
• InjuryDec 20, 2022Inflation Problem; Tear, Rip or Hole in Device Packaging; Inflation Problem; Tear, Rip or Hole in Device Packaging

  REPORTED ISSUE: THE TUBES WERE TESTED PRIOR TO INSERTION BUT IT WAS NOT UNTIL PRESSURED WAS APPLIED THAT THE CUFF DID NOT STAY INFLATED. A 2ND ATTEMPT ON PATIENT TO INTUBATE THE CUFF DID NOT STAY INFLATED; PIN HOLES WERE FOUND IN THE CUFF WHEN THEY BACKED OUT. A 3RD ATTEMPT WITH A NEW TUBE, CUFF HAD PIN HOLES AND WOULD NOT STAY INFLATED; PIN HOLES FOUND ONCE BACKED OUT. ADDITIONAL INFORMATION: PATIENT HAD BLEEDING IN THROAT. CASE ABORTED AND PATIENT SENT TO ER. PATIENT WAS ADMITTED FOR 2 DAYS WITH PNEUMOTHORAX.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16014926 ↗
• InjuryDec 20, 2022Inflation Problem; Tear, Rip or Hole in Device Packaging; Inflation Problem; Tear, Rip or Hole in Device Packaging

  REPORTED ISSUE: THE TUBES WERE TESTED PRIOR TO INSERTION BUT IT WAS NOT UNTIL PRESSURED WAS APPLIED THAT THE CUFF DID NOT STAY INFLATED. A 2ND ATTEMPT ON PATIENT TO INTUBATE THE CUFF DID NOT STAY INFLATED; PIN HOLES WERE FOUND IN THE CUFF WHEN THEY BACKED OUT. A 3RD ATTEMPT WITH A NEW TUBE, CUFF HAD PIN HOLES AND WOULD NOT STAY INFLATED; PIN HOLES FOUND ONCE BACKED OUT. ADDITIONAL INFORMATION: PATIENT HAD BLEEDING IN THROAT. CASE ABORTED AND PATIENT SENT TO ER. PATIENT WAS ADMITTED FOR 2 DAYS WITH PNEUMOTHORAX.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16014897 ↗
• InjuryDec 20, 2022Inflation Problem; Tear, Rip or Hole in Device Packaging; Inflation Problem; Tear, Rip or Hole in Device Packaging

  REPORTED ISSUE: THE TUBES WERE TESTED PRIOR TO INSERTION, BUT IT WAS NOT UNTIL PRESSURE WAS APPLIED, THAT THE CUFF DID NOT STAY INFLATED. A 2ND ATTEMPT ON THE PATIENT TO INTUBATE THE CUFF DID NOT STAY INFLATED AND PIN HOLES WERE FOUND IN THE CUFF WHEN THEY BACKED OUT. A 3RD ATTEMPT WITH A NEW TUBE WAS APPLIED, CUFF HAD PIN HOLES AND WOULD NOT STAY INFLATED. PIN HOLES WERE FOUND ONCE BACKED OUT. ADDITIONAL INFORMATION: PATIENT HAD BLEEDING IN THE THROAT. CASE WAS ABORTED AND PATIENT WAS SENT TO EMERGENCY ROOM. PATIENT WAS ADMITTED FOR 2 DAYS WITH PNEUMOTHORAX.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16014869 ↗
• MalfunctionDec 14, 2022Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE CUSTOMER NOTICED THAT THE CUFF WAS LEAKING WHILE PATIENT WAS INTUBATED AND NEEDED TO MAKE AN EXCHANGE FOR ANOTHER TUBE. THERE WAS NO REPORTED INJURY AND PATIENT CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983006 ↗
• 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 15960415 ↗
• MalfunctionNov 4, 2022Inflation Problem; Inflation Problem

  REPORTED VIA MEDWATCH REPORT. THE REPORT STATES THAT THE "PATIENT REQUIRED INTUBATION 3 TIMES DUE TO CUFF BALLOON DEFLATING AFTER IN TUBATION OF 2 ATTEMPTS. ENDOTRACHEAL TUBE SIZE 7.0. BALLOON CUFF OF 7.5 ETT STAYED INFLATED THROUGHOUT SURGICAL CASE WITHOUT INCIDENT. PATIENT'S O2 SATS, VENTILATOR TIDAL VOLUMES, AND PEAK PRESSURES MAINTAINED. NO ADVERSE EFFECTS NOTED TO PATIENT CONDITION DURING ABOVE OR PACU REPORTED. RECOMMEND REMOVING ETT 7.0 FROM SERVICE WITH REPLACEMENT 7.0 ETT MADE AVAILABLE FOR USE AND/OR CHECK CUFF BALLOON INFLATION TWICE BEFORE USE OF ETT IN CIRCULATION." ASSOCIATED MDR 3003898360-2022-00686

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729146 ↗
• MalfunctionNov 4, 2022Inflation Problem; Inflation Problem

  REPORTED VIA MEDWATCH REPORT. THE REPORT STATES THAT THE "PATIENT REQUIRED INTUBATION 3 TIMES DUE TO CUFF BALLOON DEFLATING AFTER IN TUBATION OF 2 ATTEMPTS. ENDOTRACHEAL TUBE SIZE 7.0. BALLOON CUFF OF 7.5 ETT STAYED INFLATED THROUGHOUT SURGICAL CASE WITHOUT INCIDENT. PATIENT'S O2 SATS, VENTILATOR TIDAL VOLUMES, AND PEAK PRESSURES MAINTAINED. NO ADVERSE EFFECTS NOTED TO PATIENT CONDITION DURING ABOVE OR PACU REPORTED. RECOMMEND REMOVING ETT 7.0 FROM SERVICE WITH REPLACEMENT 7.0 ETT MADE AVAILABLE FOR USE AND/OR CHECK CUFF B ALLOON INFLATION TWICE BEFORE USE OF ETT IN CIRCULATION." ASSOCIATED MDR 3003898360-2022-00648

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725633 ↗
• MalfunctionJun 3, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  COMPLAINT FROM MEDWATCH REPORT: IT WAS REPORTED "UPON OPENING AND INSPECTING THE ENDOTRACHEAL TUBE (HUDSON RCI 7.0MM) IN PREPARATION FOR ANESTHESIA/SURGERY, APPROXIMATELY 1CM LONG PLASTIC FOREIGN MATTER WAS OBSERVED IN THE LUMEN". ORIGINAL INTENDED PROCEDURE WAS REPORTED AS "INTUBATION". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597136 ↗
• MalfunctionDec 22, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "DURING A VIRTUAL IN-SERVICE THIS MORNING, [IT WAS MENTIONED] THAT ONE OF THE SHERIDAN TUBES [BEING USED] ON A PATIENT WAS LOSING AIR. ADDITIONALLY, IT WAS MENTIONED THAT "IT HAD BEEN USED ON THE PATIENT FOR 2 DAYS". PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 13061596 ↗
• MalfunctionNov 24, 2021Contamination; Contamination

  IT WAS REPORTED "[A] PIECE OF PLASTIC [WAS] FOUND INSIDE ENDOTRACHEAL TUBE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868526 ↗
• InjuryNov 19, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "WE HAD A PATIENT THAT HAD AN ETT THAT NEEDED CHANGED OUT THIS MORNING DUE TO A CUFF LEAK AGAIN". IT WAS FURTHER REPORTED THAT THE PATIENT "ENCOUNTERED FURTHER RESPIRATORY DISTRESS, HAD TO BE EXTUBATED AND REINTUBATED. PATIENT DID DESATURATE FEQUENTLY [INTO THE 70S] UNTIL TUBE WAS REPLACED". PATIENT CONDITION UNKNOWN AS IT WAS REPORTED "THE PATIENT WAS TRANSFERRED FROM OUR UNIT".

  Patient problems: Adult Respiratory Distress Syndrome; Low Oxygen Saturation

  MAUDE report 12844984 ↗
• MalfunctionAug 23, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "HVT TUBE EXPERIENCED A 'LEAK' AND WAS UNABLE TO BE INFLATED UPON INSERTION" THE DEVICE WAS REPLACED WITH NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Unintended Extubation

  MAUDE report 12356103 ↗
• MalfunctionAug 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "THE CONNECTORS ARE NOT STAYING IN AND KEEP DISCONNECTING FROM THE ET TUBE". MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL. NO PATIENT HARM OR INJURY REPORTED AT TIME OF REPORT. PATIENT CONDITION UNKNOWN AT TIME OF EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12348373 ↗
• MalfunctionAug 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "THE CONNECTORS ARE NOT STAYING IN AND KEEP DISCONNECTING FROM THE ET TUBE". MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL. NO PATIENT HARM OR INJURY REPORTED AT TIME OF REPORT. PATIENT CONDITION UNKNOWN AT TIME OF EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12348354 ↗
• MalfunctionAug 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "THE CONNECTORS ARE NOT STAYING IN AND KEEP DISCONNECTING FROM THE ET TUBE". MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL. NO PATIENT HARM OR INJURY REPORTED AT TIME OF REPORT. PATIENT CONDITION UNKNOWN AT TIME OF EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12347292 ↗
• MalfunctionJul 8, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "DR. (B)(6) PERFORMS A DIFFICULT INTUBATION WITH VIDEO LARYNGOSCOPE AND ITS INTUBATION STYLET. IMPOSSIBLE TO INFLATE THE CUFF AFTER PLACEMENT. THE DOCTOR ETUDES WITH ESCHMANN STYLET AND PLACES A NEW ETT". NO PATIENT INJURY, CONSEQUENCE, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135562 ↗
• MalfunctionJul 8, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "DR. (B)(6) PERFORMS A DIFFICULT INTUBATION WITH VIDEO LARYNGOSCOPE AND ITS INTUBATION STYLET. IMPOSSIBLE TO INFLATE THE CUFF AFTER PLACEMENT. THE DOCTOR EXTUDES WITH ESCHMANN STYLET AND PLACES A NEW ETT". NO PATIENT INJURY, CONSEQUENCE, OR DESATURATION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135530 ↗
• MalfunctionMay 17, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE CUFF PASSED THE INSPECTION; HOWEVER, IT WASN'T INFLATED FULLY AFTER INTUBATION". NO PATIENT HARM OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836240 ↗
• DeathApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "ENDOTRACHEAL TUBE HUB DISCONNECT WHILE PRONING OF THE PATIENT WHICH CAUSED THE PATIENT TO QUICKLY DESATURATE. THIS WAS DUE TO THE PATIENT'S STATUS WHICH WAS CRITICAL DUE TO COMPLICATIONS FROM COVID-19. ADDITIONALLY, DUE TO THE ENDOTRACHEAL TUBE HUB DISCONNECT THE VENT ALARMS WENT OFF AND THE PATIENT QUICKLY DESATURATED. AN ENDOTRACHEAL TUBE EXCHANGE WAS PERFORMED WITH THE USE OF A BOUGIE AND A VIDEO LARYNGOSCOPE WAS USED FOR CONFIRMATION OF THE INTUBATION. THE PATIENT WAS IN A SUPINE POSITION DURING THE DISCONNECT. THE BMI OF THE PATIENT WAS 23.9 KG. THE PEAK AIRWAY PRESSURE (PAP) WAS 37 CMH20 AND THE PEEK AND EXPIRATORY PRESSURE (PEEP) WAS 5. AS A RESULT OF THE PATIENT'S CRITICAL STATUS AND RAPID DESATURATION THE PATIENT EXPIRED".

  Patient problems: Low Oxygen Saturation

  MAUDE report 11697381 ↗
• MalfunctionApr 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CUSTOMER HAD A COMPLAINT REGARDING ETT CONNECTOR ISSUES AND LEAKAGE AROUND THE CUFF DURING USE ON A PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11679722 ↗
• MalfunctionApr 16, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "ETT CONNECTOR COMING OF THE TUBE AND THERE IS LEAKAGE AROUND THE CUFF". DEVICE REPLACED WITH NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679718 ↗

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-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-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-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 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-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-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-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,

…and 12 more.