HUDSON RCI IPN044847Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026704397525), received between Mar 3, 2023 and Sep 8, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674835 ↗
• InjuryFeb 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "I AM REPORTING AN ISSUE WITH A STYLET THAT WAS USED IN OUR UNIT WHERE THE BLUE SHEATH DISLODGED IN THE ENDOTRACHEAL TUBE DURING INTUBATION". ADDITIONAL INFORMATION: DURING INTUBATION OF AN INFANT THE STYLET CAME OUT WITHOUT THE PLASTIC SHEATH, WHICH STAYED IN THE TUBE. THE PHYSICIAN PULLED OUT THE ENDOTRACHEAL TUBE WITH THE STYLET PLASTIC IN IT. THE PATIENTS SATS DROPPED TO 40% FOR 20 SECONDS, THEY WERE BAGGED FOR 2 MINUTES TO BRING SATS BACK UP AND THEN REINTUBATED WITHOUT ISSUE. THE PATIENT WAS REPORTED AS "CRITICAL, BUT STABLE ON A VENTILATOR". THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE FROM THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18745663 ↗
• MalfunctionDec 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: "AFTER AN ATTEMPT AT INTRABRONCHIAL FOREIGN BODY EXTRACTION IN AN 11-MONTH-OLD INFANT, THE INFANT WAS INTUBATED FOR FURTHER INTENSIVE CARE UNIT THERAPY. INTUBATION INITIALLY WENT SMOOTHLY. WHEN THE STYLET WAS WITHDRAWN, IT QUICKLY BECAME APPARENT THAT A LARGE SEGMENT OF THE BLUE SHEATH OF THE STYLET WAS DISLOCATED. THE TUBE WAS REMOVED IMMEDIATELY. THE NEW INTUBATION - THIS TIME WITHOUT THE STYLET - WENT SMOOTHLY. WE THEN OPENED THE TUBE WHERE THE EVENT HAD OCCURRED AND WERE ABLE TO RETRIEVE AN 18.5 CM LONG PLASTIC SEGMENT. ADDITIONAL INFORMATION: THERE WAS NO PART OF THE STYLET LEFT IN THE PATIENT. THERE WAS NO DESATURATION DURING THE ISSUE. THE ET TUBE WITH THE SEGMENT OF THE DISLOCATED STYLET WAS REMOVED WITHIN 5 SECONDS. THERE WAS NO HARM TO THE PATIENT WHO WAS RECOVERED AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18289552 ↗
• InjuryMar 3, 2023Flaked; Flaked

  REPORTED ISSUE: PLASTIC COATING OF STYLET DETACHED FROM STYLET WHEN STYLET REMOVED FROM ENDOTRACHEAL TUBE AFTER INTUBATION. 10 CM PIECE OF PLASTIC COATING REMAINED IN ETT WHICH WAS IN INFANT'S ESOPHAGUS. INFANT ELECTIVELY EXTUBATED DUE TO THE PLASTIC PIECE IN ORIGINAL ETT AND REINTUBATED. NO REPORTED INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 16479435 ↗