HUDSON RCI IPN044800Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04026704397419), received between Sep 6, 2023 and Nov 25, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Material Perforation; Gas/Air Leak; Material Perforation; Gas/Air Leak

  IT WAS REPORTED THAT: "LEAKAGE WAS NOTED DUE TO PERFORATION. CHANGED TO ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT HARM OR INJURY." ASSOCIATED COMPLAINTS: 3003898360-2024-01488, 3003898360-2024-01502, 3003898360-2024-01501, 3003898360-2024-01500 AND 3003898360-2024-01486.

  Patient problems: Insufficient Information

  MAUDE report 20770496 ↗
• MalfunctionNov 25, 2024Material Perforation; Gas/Air Leak; Material Perforation; Gas/Air Leak

  IT WAS REPORTED THAT: "LEAKAGE WAS NOTED DUE TO PERFORATION. CHANGED TO ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT HARM OR INJURY." ASSOCIATED COMPLAINTS: 3003898360-2024-01488, 3003898360-2024-01502, 3003898360-2024-01500 AND 3003898360-2024-01486.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770477 ↗
• MalfunctionNov 25, 2024Material Perforation; Gas/Air Leak; Material Perforation; Gas/Air Leak

  IT WAS REPORTED THAT: "LEAKAGE WAS NOTED DUE TO PERFORATION. CHANGED TO ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT HARM OR INJURY." ASSOCIATED COMPLAINTS: 3003898360-2024-01488, 3003898360-2024-01502, 3003898360-2024-01501, 3003898360-2024-01500 AND 3003898360-2024-01486.

  Patient problems: Insufficient Information

  MAUDE report 20770452 ↗
• MalfunctionNov 25, 2024Material Perforation; Gas/Air Leak; Material Perforation; Gas/Air Leak

  IT WAS REPORTED THAT: "LEAKAGE WAS NOTED DUE TO PERFORATION. CHANGED TO ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT HARM OR INJURY." ASSOCIATED COMPLAINTS: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770434 ↗
• MalfunctionOct 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT (B)(6) 2024, DURING THE PROCESS OF TRACHEAL INTUBATION FOR GENERAL ANESTHESIA, THE PATIENT'S AIRWAY PRESSURE SU DDENLY INCREASED, AND AFTER CHECKING, IT WAS FOUND THAT THE REINFORCED TRACHEA WAS BENT, SO IT WAS RESET AND FIXED, AND IT WAS OBSERVED THAT THE AIRWAY PRESSURE RETURNED TO NORMAL. DURING SPUTUM SUCTIONING, THE LUMEN OF THE ENDOTRACHEAL TUBE WAS FOUND TO BE DEFORMED, AND IT WAS DIFFICULT TO PLACE THE SPUTUM TUBE. AFTER EXTUBATION, IT WAS OBSERVED THAT THE WIRE IN THE ENDOTRACHEAL TUBE WAS DISPLACED, AND THERE WAS NO SUPPORTING ABILITY OF THE UNPROTECTED PORTION OF THE WIRE, WHICH DID NOT BRING ADVERSE CONSEQUENCES TO THE PATIENT, AND THE ANESTHESIA PROCESS WAS SMOOTH. THERE WAS NO REPORTED PATIENT HARM FROM THE INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558313 ↗
• MalfunctionSep 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT: "DURING INTUBATION, THE ANESTHESIOLOGIST, AT THE TIME OF INFLATING THE BALLOON OF THE TUBE, IDENTIFIES THE PRESENCE OF LEAKAGE, PRESSURE IS NOT MAINTAINED, THE TUBE IS CHANGED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190732 ↗
• MalfunctionSep 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT: "ANESTHESIOLOGIST REPORTS THAT DURING THE PLACEMENT OF THE ENDOTRACHEAL TUBE, LEAKAGE IS IDENTIFIED IN THE BAL LOON, SO THE TUBE IS CHANGED." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 20188590 ↗
• MalfunctionSep 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. THE PATIENT WAS REPORTED AS FINE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143969 ↗
• InjuryDec 27, 2023Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT "THE PATIENT HAD DIFFICULTY BREATHING. BEFORE UNDERGOING TRACHEOSTOMY, THE HEAD NURSE INSERTED AN TRACHEOSTOMY CATHETER INTO THE PATIENT. HOWEVER, THE PATIENT EXPERIENCED POOR VENTILATION AND AIRWAY OBSTRUCTION. THE NURSE IMMEDIATELY REPLACED THE CATHETER FOR THE PATIENT". PER THE CUSTOMER, NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401551 ↗
• MalfunctionSep 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE PRIOR TO USE ON PATIENT THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691181 ↗
• MalfunctionSep 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE PRIOR TO USE ON PATIENT THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690899 ↗
• MalfunctionSep 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE PRIOR TO USE ON PATIENT THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690879 ↗
• MalfunctionSep 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE PRIOR TO USE ON PATIENT THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690838 ↗