HUDSON RCI IPN048998Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14026704617422), received between Sep 1, 2021 and May 5, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED "PRIOR TO USE ON PATIENT, ADAPTOR BROKE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288294 ↗
• MalfunctionFeb 21, 2022Break; Break

  IT WAS REPORTED THAT: "COMPLETE RUPTURE OF THE CONNECTOR ON THE TRACHEAL LINE". ADDITIONAL INFORMATION PROVIDED STATED THAT "THE DEVICE WAS FOUND BROKEN WHEN THE PACKAGING WAS OPENED". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568873 ↗
• MalfunctionNov 17, 2021Fracture; Fracture

  IT WAS REPORTED "CLINICIANS ARE OPENING THE PACKAGE AND NOTICING THAT THE CONNECTION PIECE IS CRACKED AND DAMAGED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832539 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED "THE END THAT HAS THE "T" CONNECTOR IS LITERALLY BREAKING AWAY FROM THE RUBBER TUBE". UNKNOWN WHERE THE ISSUE WAS FIRST OBSERVED AT TIME OF REPORT. UNKNOWN PATIENT CONDITION AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 12484985 ↗
• MalfunctionSep 2, 2021Break; Break

  THE 41FR TUBES WERE FOUND TO BE "BROKEN". NO PATIENT HARM OR INJURY REPORTED. CONNECTOR PIECE REPORTED TO BE REPLACED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 12412950 ↗
• MalfunctionSep 2, 2021Break; Break

  THE 41FR TUBES WERE FOUND TO BE "BROKEN". NO PATIENT HARM OR INJURY REPORTED. CONNECTOR PIECE REPORTED TO BE REPLACED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 12412945 ↗
• MalfunctionSep 2, 2021Break; Break

  THE 41FR TUBES WERE FOUND TO BE "BROKEN". NO PATIENT HARM OR INJURY REPORTED. CONNECTOR PIECE REPORTED TO BE REPLACED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 12412930 ↗
• MalfunctionSep 2, 2021Break; Break

  DURING USE ON A PATIENT, THE 41FR TUBES WERE FOUND TO BE "BROKEN". THE REPLACEMENT WAS ALSO FOUND "BROKEN IN PACKAGE DURING A CRITICAL MOMENT AND DUE TO THE DELAY IT CAUSES TO THE PROCEDURE AS THE TUBES NEED TO BE EXCHANGED". THIRD 41FR ETT "FORTUNATELY WORKED". NO PATIENT HARM OR INJURY REPORTED. CONNECTOR PIECE REPORTED TO BE REPLACED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 12412859 ↗
• InjurySep 1, 2021Break; Break

  DURING USE ON A PATIENT, THE 41FR TUBES WERE FOUND TO BE "BROKEN". IT WAS REPORTED THE "PATIENT DESATURATED INTO THE 50'S BEFORE WE COULD FIGURE OUT THE PROBLEM AND GET A REPLACEMENT". THE REPLACEMENT WAS ALSO FOUND "BROKEN IN PACKAGE DURING A CRITICAL MOMENT AND DUE TO THE DELAY IT CAUSES TO THE PROCEDURE AS THE TUBES NEED TO BE EXCHANGED". THIRD 41FR ETT "FORTUNATELY WORKED". CONNECTOR PIECE REPORTED TO BE REPLACED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION TO THE CUSTOMER HAS BEEN UNSUCCESSFUL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12406420 ↗