RUSCH IPN044687Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704547630), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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. How this data works · Data updated Oct 13, 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-1851-2023 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 8, 2022Open, Classified

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

   Z-1011-2023 · Root cause: Process control · 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.

• MalfunctionJul 13, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED: "HOSPITAL WAS USING THE ENDOTRACHEAL TUBE AND SAID THE CUFF WAS NOT DEFLATING WHEN THEY WERE GOING TO EXTRACT THE ETT. ADDITIONAL INFORMATION RECEIVED: THE PILOT BALLOON WAS WHERE THE ISSUE WAS. THE CONNECTION POINT WHERE THE SYRINGE AND THE PILOT BALLOON MEET SPECIFICALLY. NO MEDICAL INTERVENTION WAS REQUIRED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162995 ↗

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-1890-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
• Z-1883-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
• Z-1887-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
• Z-1888-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
• Z-1845-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550
• Z-1960-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
• Z-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
• Z-1899-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1848-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
• Z-1891-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
• Z-1959-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
• Z-1965-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
• Z-1889-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
• Z-1884-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050

…and 19 more.