HUDSON RCI IPN044799Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04026704397402), received between May 19, 2022 and Jan 16, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Material Deformation

  IT WAS REPORTED THAT: "(B)(6) 2025, AN ANESTHESIOLOGIST PLACED A TUBE FOR A PATIENT WITH PROSTATE CANCER. APPROXIMATELY TWO HOURS INTO THE SURGERY, THE PATIENT'S AIRWAY PRESSURE INCREASED. UPON EXAMINATION, IT WAS FOUND THAT THE INNER MEMBRANE OF THE TUBE HAD BULGED, ALMOST COMPLETELY OBSTRUCTING THE TUBE. WE HAVE NOT RECEIVED ANY REPORTS OF PATIENT HARM FROM THIS INCIDENT. IT OCCURRED NEAR THE END OF SURGERY, WHEN A SUDDEN RISE IN AIRWAY PRESSURE LED THE ANESTHESIOLOGIST TO SUSPECT AN ASTHMA ATTACK AND INITIATE EMERGENCY PROCEDURES. FORTUNATELY, THE ISSUE WAS IDENTIFIED PROMPTLY , AND THE PATIENT DID NOT EXPERIENCE PROLONGED LOW OXYGEN SATURATION. THE PATIENT'S PACU OBSERVATION WAS LONGER THAN FOR SIMILAR SURGERIES TO ENSURE NO ADDITIONAL INJURIES AFTER FULL AWAKENING. FORTUNATELY , RECOVERY WAS UNAFFECTED. OXYGEN SATURATION BRIEFLY DROPPED BELOW 95%, BUT DUE TO PROMPT DETECTION, PROLONGED HYPOXEMIA DID NOT OCCUR. THE ANESTHESIOLOGIST HAD TESTED THE TUBE INTEGRITY AND CUFF FOR LEAKS BEFORE USE.".

  Patient problems: Airway Obstruction; Low Oxygen Saturation

  MAUDE report 24092794 ↗
• MalfunctionDec 1, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT: "(B)(6) 2025, ET TUBE WAS COMPLETELY BLOCKED UNDER PRESSURE DURING USE AND COULD NOT BE USED. THERE WAS NO HEALTH CONSEQUENCES FOR THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680123 ↗
• InjuryJul 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE SPIRAL COIL KEEPS GETTING KINKED." THE PATIENT DESATED BELOW 95%. THEY WERE REPORTED AS FINE AFTER THE IN CIDENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19653682 ↗
• MalfunctionApr 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." THIS OCCURED PRIOR TO USE; THERFORE, NO PAITENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011005 ↗
• MalfunctionApr 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT." NO PATIENT INVOVLEMENT OCCURED. THREFORE, NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010715 ↗
• InjuryJan 2, 2024Material Separation; Medical Gas Supply Problem; Material Separation; Medical Gas Supply Problem

  IT WAS REPORTED THAT: THE INNER LAYER OF THE TUBE SEPARATED FROM THE OTHER PART OF THE TUBE DURING THE PROCEDURE. THIS INNER LAYER GOT BIGGER AND CREATED A SMALL BUMP THAT OBSTRUCTED THE TUBE. CLINICAL CONSEQUENCES: INCREASE OF VENTILATION PRESSURE, DIFFICULT TO PROPERLY VENTILATE THE PATIENT. PATIENT DESATURATED, EXTUBATION AND MANUAL VENTILATION DONE TO RESOLVE THE DESATURATION. PATIENT IS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18424243 ↗
• InjuryOct 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, "PATIENT WAS INTUBATED AND PLACED IN PRONE POSITION FOR SPINAL SURGERY, 1.5 HOURS INTO THE PROCEDURE THE ANEST HETIST WAS UNABLE TO VENTILATE THE PATIENT, CASE WAS ABANDONED AND PATIENT RETURN TO SUPINE POSITION. COULD NOT PASS Y SUCKER DOWN ETT TUBE OR AMBU INTUBATING SCOPE, PATIENT THEN EXTUBATED AND REINTUBATED WITH NEW TUBE AND WAS ABLE TO BE VENTILATED AND STABILIZED. THE ETT LOOKS TO BE OCCLUDED AND NOT ABLE TO ADVANCE ANYTHING DOWN INSIDE OF IT - UNSURE WHY THIS SITUATION OCCURRED 1.5 HOURS INTO PROCEDURE. THE ANESTHETIST SAID AIRWAY PRESSURE INCREASED WITH C02, MORE MUSCLE RELAXANT GIVEN DIDN'T RESOLVE ISSUE, PATIENT DIFFICULT TO VENTILATE, HAD NO OPTION BUT TO CEASE SURGICAL PROCEDURE, UNSURE IF WAS A SPUTUM PLUG INITIALLY BUT FEEL IT IS MORE TUBE RELATED, CHECKED ANESTHESIA CIRCUIT WHICH WAS FINE, WAS ABLE TO VENTILATE PATIENT FOLLOWING EXTUBATION WITHOUT ANY ISSUES". NO PATIENT HARM, DESATURATION, OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 17855553 ↗
• MalfunctionOct 5, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543867 ↗
• MalfunctionSep 23, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470497 ↗
• MalfunctionAug 23, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274530 ↗
• MalfunctionMay 19, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "FOLLOWING INTUBATION OF PATIENT, IT WAS NOTED THAT THERE WAS A LEAKY PILOT CUFF. EXTRA AIR WAS REQUIRED SEVERAL TIMES DURING PROCEDURE, HOWEVER PROCEDURE CONTINUED UNEVENTFULLY AND THERE WAS NO ISSUE FOR PATIENT.' PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435258 ↗