HUDSON RCI IPN048959Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 14026704617071), received between Dec 1, 2021 and Apr 3, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED ISSUE: THE DOCTOR FOUND CUFF LEAKAGE WHEN USING ON A PATIENT. A NEW DEVICE WAS USED AND THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667626 ↗
• MalfunctionMar 15, 2023Obstruction of Flow; Obstruction of Flow

  REPORTED ISSUE: THE DOCTOR FOUND THE TUBE BLOCKED WHEN USING IT ON A PATIENT. A NEW TUBE WAS USED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550894 ↗
• MalfunctionJan 24, 2023Obstruction of Flow; Obstruction of Flow

  REPORTED EVENT: THE DOCTOR FOUND TUBE BLOCKED WHILE IN THE CLINICAL SETTING BEFORE USING IT ON THE PATIENT. A NEW DEVICE WAS USED AND THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233143 ↗
• MalfunctionNov 30, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890598 ↗
• MalfunctionOct 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: "THE DOCTOR FOUND PACKAGE LABEL INFO IS INCONSISTENT WITH PRODUCT WHEN CLINICAL SETTING BEFORE USING ON PATIENT AT THE SAME TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606777 ↗
• MalfunctionOct 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: "THE DOCTOR FOUND PACKAGE LABEL INFO IS INCONSISTENT WITH PRODUCT WHEN CLINICAL SETTING BEFORE USING ON PATIENT AT THE SAME TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606765 ↗
• MalfunctionOct 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: "THE DOCTOR FOUND PACKAGE LABEL INFO IS INCONSISTENT WITH PRODUCT WHEN CLINICAL SETTING BEFORE USING ON PATIENT AT THE SAME TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606692 ↗
• MalfunctionOct 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: "THE DOCTOR FOUND PACKAGE LABEL INFO IS INCONSISTENT WITH PRODUCT WHEN CLINICAL SETTING BEFORE USING ON PATIENT AT THE SAME TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606675 ↗
• MalfunctionSep 28, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "THE DOCTOR FOUND THE TUBE OCCLUSION WHICH AFFECTED THE VENTILATION OF THE MACHINE WHEN USING ON PATIENT. NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499085 ↗
• MalfunctionAug 23, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277798 ↗
• MalfunctionAug 23, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277797 ↗
• MalfunctionAug 23, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277782 ↗
• MalfunctionJun 10, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE PHYSICIAN INTUBATES THE PATIENT WITH A REINFORCED TUBE WITH A #7.0 C/G STEEL CORE. AT THE TIME OF INTUBATING THE PATIENT, THE BALLOON IS INFLATED. HOWEVER, MINUTES LATER, THE PHYSICIAN REALIZES THAT THE BALLOON IS NO LONGER INFLATED AS THE PATIENT IS ALREADY INTUBATED. HE CONTINUED TO EXTUBATE AND INSERT ANOTHER TUBE WITH THE SAME CALIBER AND THE SAME LOT NUMBER, AND THE NEW DEVICE WAS LEFT WORKING WITHOUT ANY COMPLICATIONS". NO INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14661363 ↗
• MalfunctionJun 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE ANESTHESIOLOGIST INTUBATES THE PATIENT, AT THE MOMENT OF WANTING TO INFLATE THE BALLOON IT NO LONGER INFLATES, THE ANESTHESIOLOGIST COMMENTS THAT IT WAS POSSIBLY PUNCTURED. THE ANESTHESIOLOGY ASSISTANT CONFIRMS THAT THE BALLOON WAS IN PERFECT CONDITION BEFORE THE PROCEDURE TO INTUBATE". THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14631912 ↗
• MalfunctionMar 17, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE TWIST 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 13794583 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND BALLOON BROKEN WHEN USING ON PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908326 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED "THE DOCTOR FOUND BALLOON BROKEN WHEN USING ON PATIENT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908287 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT "THE DOCTOR FOUND BALLOON BROKEN WHEN DOING INFLATION DURING CLINICAL SETTING BEFORE USING ON PATIENT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908239 ↗