RUSCH IPN041505Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704341457), received between Aug 30, 2024 and Aug 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

34 other recalls cover devices cleared under the same FDA submission (K961837); 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.

Recalls naming this device

1. May 25, 2023Open, Classified

   Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

   Z-1891-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 8, 2022Open, Classified

   Potential for pilot balloon non-inflation or cuff non-deflation.

   Z-1011-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CLINICAL STAFF AT THE HOSPITAL THAT: " WHEN CANNULATING THE PATIENT, THE PRESENCE OF A LEAK IN THE ENDOTRACHEAL TUBE BALLOON IS DETECTED." THERE WAS NO HARM TO THE PATIENT FROM THE INCIDENT. NO DESATURATION OCCURRED. THE CURRENT PATIENT CONDITION IS REPORTED AS DECEASED, BUT IT IS NOT DERIVED FROM THE MEDICAL DEVICE INCIDENT, BUT FROM THE DIAGNOSIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106600 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961837. One submission often covers many models, so check the product and lot details in each record.

• Z-1851-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
• Z-1883-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
• Z-1899-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
• Z-1965-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
• Z-1893-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1889-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
• Z-1849-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
• Z-1847-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
• Z-1959-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
• Z-1964-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
• Z-1961-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
• Z-1892-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
• Z-1888-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
• Z-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100

…and 19 more.