RUSCH IPN041501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704341419), 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-1887-2023 · 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 TE HOSPITAL THAT: "PATIENT PRESENTED BRADYPNEA AND APNEA, WITH BRADYCARDIA AND SUBSEQUENT CARDI ORESPIRATORY ARREST DUE TO HYPOXIA, REQUIRING SUPPORT WITH VENTILATION AND CARDIOPULMONARY RESUSCITATION, INTUBATED AT THE FIRST ATTEMPT, BUT DUE TO AIR LEAKAGE WAS CHANGED TO A 6.5 CANNULA WITH FIXED BALLOON IN 16". ADDITIONAL INFOMRATION REPORTED BY THE CLINICAL STAFF: "DEATH (B)(6) 2023. CARDIORESPIRATORY ARREST UNRELATED TO THE DEVICE INCIDENT. THE ISSUE WAS RESOLVED CHANGING THE CANNULA WITH ANOTHER CANNULA OF THE SAME CALIBER AND BRAND. THE AIR LEAK WAS AFTER DE ARREST. THE AIR LEAK, DIDN'T DELAY THE HEALTH CARE. THE PATIENT DIDN'T SUFFER HYPOXIA WHEN THE CANNULA WAS CHANGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107521 ↗

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-1847-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
• Z-1893-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
• Z-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
• Z-1884-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050
• 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-1882-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1890-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
• Z-1881-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
• Z-1899-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
• Z-1848-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
• Z-1849-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
• Z-1846-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
• Z-1958-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050

…and 19 more.