HUDSON RCI IPN044766Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04026704397037), received between Feb 26, 2018 and Aug 6, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "ET TUBES BURST BALLOONS UPON INSERTION IN PATIENT.".

  Patient problems: Insufficient Information

  MAUDE report 22724367 ↗
• MalfunctionJul 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: "DURING AN EXCISION LESION RECTUM TEM (TRANSANAL ENDOSCOPIC SURGERY)." ANESTHESIOLOGIST NOTE IN CHART: "DEFECTIVE ETT NOTED (SPLIT IN LONGITUDINAL DIRECTION AT THE TOP NEAR THE CONNECTOR). SURGICAL TEAM INFORMED. PREOXYGENATED. TUBE EXCHANGE ATTEMPTED BUT DIFFICULT PASSING OVER ARYTENOIDS DESPITE ASSISTANCE OF LARYNGOSCOPY AND ASSOCIATED HEMODYNAMIC RESPONSE. THEREFORE, TUBE EXCHANGE CATHETER REMOVED, ADDITIONAL PROPOFOL ADMINISTERED, EASY BAG MASK VENTILATION WITH ORAL AIRWAY. REDO LARYNGOSCOPY WITH STYLETTED ETT, UNEVENTFUL INTUBATION. NO DESATURATION THROUGHOUT INTERVENTION. INCIDENT REPORT FOR DEFECTIVE ETT SUBMITTED."

  Patient problems: Insufficient Information

  MAUDE report 22411848 ↗
• MalfunctionDec 5, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "INTUBATED PATIENT, LEAK AND UNABLE TO MAINTAIN SEAL. ACCORDING TO THE ANESTHETIST THAT WAS WORKING, THE BALLOON WAS TESTED PRIOR TO INTUBATION AND NO OBVIOUS ISSUES APPEARED AT THAT TIME. THE ETT IN QUESTION WAS REMOVED FROM THE PATIENT AND REPLACE WITH ANOTHER ONE OF DIFFERENT BRAND/SIZE. NO HARM OR HEALTH CONSEQUENCES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851526 ↗
• InjuryNov 29, 2024Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED THAT: "DURING PROCEDURE, PRODUCT KINKED AND WAS OBSTRUCTED DURING SURGERY (TOO SOFT). THE PATIENT EXPERIANCED HIGH A IRWAY PRESSURES, BRAIN HERNIATION DURING NEUROSURGERY. THE SATURATIONS DROPPED BELOW 95% FOR 5 MINUTES."

  Patient problems: Insufficient Information

  MAUDE report 20810192 ↗
• MalfunctionApr 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "DURING A CASE LAST WEEK USER EXPERIENCED SOME DIFFICULTY MAINTAINING AIRWAY PRESSURES AND DELIVERING IDEAL TIDAL VOLUMES. THE CUFF OF OUR ET TUBE WOULD NOT HOLD ANY AIR WITH THE SYRINGE. AFTER RE-INTUBATING THE PATIENT, WE EXAMINED THE ET TUBE THAT WAS REMOVED. THE DISTAL CUFF OF THE ET TUBE HAD A LARGE HOLE SPONTANEOUSLY RUPTURING INTRAOP. THE CUFF WAS TESTED/INFLATED PRIOR TO STARTING THE CASE. FOLLOWING INDUCTION & INTUBATION, THE CUFF WAS INFLATED WITHOUT ISSUE, & NO LEAK. THE INTUBATION WAS SMOOTH, ATRAUMATIC, & PATIENT WAS EDENTULOUS. THE CASE WAS NOT LAPAROSCOPIC." THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215076 ↗
• MalfunctionMar 23, 2024Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT "ANESTHESIOLOGIST TESTED CUFF INFLATION FOR ET TUBE. CUFF DID NOT INFLATE. AIR LEAKED OUT OF THE SIDE OF THE TUBE DUE TO THE TUBE BEING SEVERED ALMOST COMPLETELY THROUGH". NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966230 ↗
• MalfunctionMar 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: ISSUE IS THAT THE ADAPTOR ON THE PATIENT'S ENDOTRACHEAL TUBE CONTINUOUSLY KEEPS COMING OUT OF THE ETT.

  Patient problems: Insufficient Information

  MAUDE report 18903836 ↗
• MalfunctionFeb 26, 2018Loose or Intermittent Connection

  THE ADAPTOR KEEPS COMING LOOSE FROM THE TUBE. AS A RESULT, THE PATIENT REQUIRED AN ET TUBE REPLACEMENT. THIS OCCURRED ON ONE OF OUR VENTED PATIENTS. THIS PROBLEM HAS HAPPENED MULTIPLE TIMES OVER THE LAST 3 MONTHS. MANUFACTURER RESPONSE FOR TUBE, TRACHEAL (W/WO CONNECTOR), HUDSON RCI (PER SITE REPORTER): NONE YET.

  Patient problems: No Information

  MAUDE report 7295695 ↗

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-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-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-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-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-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-1956-2019 · Jun 7, 2019 · Terminated
  Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
• 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-1759-2019 · May 24, 2019 · Terminated
  Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
• 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-1765-2019 · May 24, 2019 · Terminated
  Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 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.