RUSCH IPN040971Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704340986), received between Mar 9, 2021 and Oct 17, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K990619); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "THE DOCTOR FOUND INFLATION PROBLEM PRIOR TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618989 ↗
• MalfunctionMar 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "INFLATION DEFECT FOUND DURING OPERATION USE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13844328 ↗
• MalfunctionMar 4, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND INFLATION PROBLEM (CUFF LEAKAGE) DURING PROCEDURE. SO, IT COULDN'T FIX". ADDITIONAL INFORMATION WAS NOT PROVIDED AT THE TIME OF REPORT. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13667495 ↗
• MalfunctionOct 15, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE PILOT BALLOON LEAKING DURING PROCEDURE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638728 ↗
• MalfunctionSep 23, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE DOCTOR FOUND BALLON LEAKING AND PILOT BALLON DIDN T INFLATE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518574 ↗
• MalfunctionMar 9, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE BALLOON INFLATION WAS NOT NORMALLY OPERATED AND THE PRODUCT WAS NOT FIXED DURING INTUBATION". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447119 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990619. One submission often covers many models, so check the product and lot details in each record.

• Z-1124-2015 · Dec 12, 2014 · Terminated
  RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be