RUSCH IPN041498Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704341389), received between Feb 16, 2023 and Dec 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation 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-1884-2023 · 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE, THE CUFF WAS NOT INFLATING. ADDITIONAL INFORMATION RECEIVED STATES THAT, "THE DEFECT WAS NOTICED IMMEDIATELY FOLLOWING INTUBATION, UPON ATTEMPT TO INFLATE THE CUFF. THE DEFECTIVE TUBE WAS REMOVED AND REPLACED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "HEALTHY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832173 ↗
• MalfunctionFeb 16, 2023Use of Device Problem; Use of Device Problem

  REPORTED EVENT: THE PATIENT WHO IS UNDER INVASIVE MECHANICAL VENTILATION, BALLOON NOT INFLATED, ORO-INTUBATED WITH A NUMBER 5.0 OROTRACHEAL CANNULA WITH A BALLOON FIXED 12 CM FROM THE DENTAL ARCH AT 6:30 A.M. ON 10-17-22 AN EVENT OF INCIDENTAL EXTUBATION OCCURS, HE IS REINTUBATED ON THE FIRST ATTEMPT WITH CANNULA FROM NUMBER 5.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386427 ↗

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-1962-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
• Z-1891-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1964-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
• 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-1883-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
• Z-1961-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
• 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-1882-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
• Z-1959-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
• Z-1885-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
• Z-1890-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080

…and 19 more.