HUDSON RCI IPN049000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 14026704617446), received between Jun 7, 2021 and Jun 9, 2023 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098563 ↗
• MalfunctionNov 10, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CONNECTOR BROKEN BEFORE USING ON PATIENT. THEN CHANGED TO A NEW ONE. NO IMPACT ON PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770802 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CONNECTOR BROKEN WHEN USING IT ON THE PATIENT. THEN CHANGED IT TO A NEW ONE." NO INJURY, HARM, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738301 ↗
• MalfunctionOct 10, 2022Break; Break

  IT WAS REPORTED THAT: "THE NURSE FOUND CONNECTOR BROKEN WHEN OPENING THE PACKAGE BEFORE USING ON PATIENT. THEN CHANGED NEW ONE. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572814 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335426 ↗
• MalfunctionAug 23, 2022Leak/Splash; Leak/Splash

  ALLEGED QUALITY ISSUE/INCIDENT: "PATIENT WAS INTUBATED WITH BRONCHIAL TUBE FOR THE SURGERY, HOWEVER, AIR LEAKING SITUATION KEPT OCCURRING. THEN, CLINICIAN FOUND OUT THAT THE LEAKING CAME FROM THE CRACK OF Y CONNECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274780 ↗
• MalfunctionAug 23, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274679 ↗
• MalfunctionAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274666 ↗
• MalfunctionAug 23, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT: "THE ANESTHESIOLOGIST ADJUSTED THE POSITION OF THE DOUBLE-LUMEN TRACHEA MANY TIMES, REFLECTING THAT THE RIGHT-SIDED DOUBLE-LUMEN TRACHEA WAS NOT SUITABLE FOR THE PATIENT'S LUNG SURGERY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274601 ↗
• MalfunctionAug 2, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145691 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145643 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145404 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145389 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145361 ↗
• MalfunctionApr 29, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT." NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255770 ↗
• MalfunctionApr 22, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189467 ↗
• MalfunctionApr 22, 2022Fracture; Fracture

  IT WAS REPORTED "CRACKED SWIVEL ADAPTERS". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189425 ↗
• MalfunctionApr 22, 2022Fracture; Fracture

  IT WAS REPORTED "CRACKED SWIVEL ADAPTERS". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189358 ↗
• MalfunctionApr 14, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110901 ↗
• MalfunctionApr 14, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110880 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED "THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102599 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED "THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102514 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED "THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102457 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND CONNECTOR BOKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053072 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED "THE DOCTOR FOUND CONNECTOR BROKEN DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052981 ↗