HUDSON RCI IPN048996Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 14026704617408), received between Feb 25, 2021 and Jul 31, 2023 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF CANNOT BE INFLATED WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT. INVOLVED 1 PC." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17429576 ↗
• MalfunctionJul 21, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, "THE Y CONNECTOR COULD NOT BE ATTACHED TO THE MACHINE TIGHTLY, AIR LEAKING HAPPENED." NO MEDICAL INTERVENTION REQUIRED, "THE SITUATION WAS FOUND IN TIME". NO PATIENT HARM, DESATURATION, OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372314 ↗
• MalfunctionJun 15, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF CANNOT BE INFLATED 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 17139071 ↗
• MalfunctionMar 24, 2023Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE DOCTOR FOUND CUFF CANNOT BE INFLATED BEFORE USING IT ON THE PATIENT; IT WAS CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616374 ↗
• MalfunctionMar 24, 2023Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE DOCTOR FOUND CUFF CANNOT BE INFLATED BEFORE USING IT ON THE PATIENT; IT WAS CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616141 ↗
• MalfunctionMar 24, 2023Inflation Problem; Inflation Problem

  REPORTED ISSUE: THE DOCTOR FOUND CUFF CANNOT BE INFLATED BEFORE USING IT ON THE PATIENT; IT WAS CHANGED TO A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616076 ↗
• MalfunctionMar 24, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING CLINICAL SETTING BEFORE USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615481 ↗
• MalfunctionMar 17, 2023Break; Break

  REPORTED ISSUE: THE DOCTOR FOUND THE CONNECTOR BROKEN WHEN USING IT ON A PATIENT. IT WAS CHANGED TO A NEW ONE; NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567460 ↗
• MalfunctionMar 17, 2023Break; Break

  REPORTED ISSUE: THE DOCTOR FOUND THE CONNECTOR BROKEN WHEN USING IT ON A PATIENT. IT WAS CHANGED TO A NEW ONE; NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567364 ↗
• MalfunctionFeb 27, 2023Break; Break

  REPORTED ISSUE: THE DOCTOR FOUND THE CONNECTOR BROKEN WHEN IN A CLINICAL SETTING BEFORE USING IT ON A PATIENT. A NEW ONE WAS USED. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448456 ↗
• MalfunctionOct 11, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576970 ↗
• MalfunctionAug 29, 2022Leak/Splash; Leak/Splash

  COMPLAINT REPORTS THAT: THE BRONCHIAL BALLOON LEAKED, DURING USE ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15310229 ↗
• MalfunctionAug 24, 2022Break; Break

  ALLEGED QUALITY ISSUE/INCIDENT: "PATIENT WAS INTUBATED, WHEN CLINICIAN ATTEMPTED TO ATTACH TO Y CONNECTOR, IT JUST BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282262 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CUFF DETACHED FROM THE TUBE DURING CLINICAL SETTING BEFORE USING ON PATIENT. NO IMPACT ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277623 ↗
• MalfunctionAug 2, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT. THEN CHANGED NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145498 ↗
• MalfunctionAug 2, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145335 ↗
• MalfunctionAug 2, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145240 ↗
• 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 15145215 ↗
• MalfunctionJun 8, 2022Break; Break

  COMPLAINT FROM MAUDE DATABASE: "NARRATIVE FROM STAFF: AFTER INTUBATING WITH LEFT DOUBLE LUMEN TUBE THE TWO-WAY SPLITTER FROM THE Y-TUBING BROKE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14631484 ↗
• 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 14189502 ↗
• MalfunctionApr 13, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON PATIENT AND CHANGED NEW ONE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102065 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED "THE Y CONNECTOR WAS FOUND BROKEN WHEN CLINICAL STAFF OPEN IT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475884 ↗
• MalfunctionDec 16, 2021Fracture; Fracture

  IT WAS REPORTED "PURCHASED DOUBLE LUMEN BRONCH TUBE AND THE FO DOUBLE SWIVEL CONNECTOR ASSEMBLY/ 1 WYE HAS A CRACK IN THE PLASTIC AT THE ELBOW". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022495 ↗
• MalfunctionDec 16, 2021Fracture; Fracture

  IT WAS REPORTED "PURCHASED DOUBLE LUMEN BRONCH TUBE AND THE FO DOUBLE SWIVEL CONNECTOR ASSEMBLY/ 1 WYE HAS A CRACK IN THE PLASTIC AT THE ELBOW". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022438 ↗
• MalfunctionDec 16, 2021Fracture; Fracture

  IT WAS REPORTED "PURCHASED DOUBLE LUMEN BRONCH TUBE AND THE FO DOUBLE SWIVEL CONNECTOR ASSEMBLY/ 1 WYE HAS A CRACK IN THE PLASTIC AT THE ELBOW". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022420 ↗