RUSCH IPN041504Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14026704341440), received between Jan 22, 2023 and May 8, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

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-1890-2023 · 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT "ETT TUBES ARE TOO STIFF, ARE EASILY KINKED OFF, AND THE CONNECTOR FALLS OFF EASILY." NO PATIENT INVOLVEMENT. 3 ISSUES REPORTED. ASSOCIATED MDRS:8040412-2026-00063, 8040412-2026-00056.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129109 ↗
• MalfunctionMay 8, 2026Decoupling

  IT WAS REPORTED THAT "ETT TUBES ARE TOO STIFF, ARE EASILY KINKED OFF, AND THE CONNECTOR FALLS OFF EASILY." NO PATIENT INVOLVEMENT. 3 ISSUES REPORTED. ASSOCIATED MDRS:8040412-2026-00063, AND 8040412-2026-00057.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128850 ↗
• MalfunctionMay 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "ETT TUBES ARE TOO STIFF, ARE EASILY KINKED OFF, AND THE CONNECTOR FALLS OFF EASILY." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128253 ↗
• MalfunctionFeb 2, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  REPORTED EVENT: END CONNECTOR LOOSE FROM ETT TUBE; DOES NOT REMAIN SNUG. NO INJURY REPORTED. (ASSOCIATED COMPLAINT 8040412-2023-00020)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284379 ↗
• MalfunctionFeb 2, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  REPORTED EVENT: END CONNECTOR LOOSE FROM ETT TUBE; DOES NOT REMAIN SNUG. NO INJURY REPORTED.(ASSOCIATED COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284255 ↗
• MalfunctionJan 31, 2023Disconnection; Disconnection

  IT IS REPORTED THAT "ON MULTIPLE OCCASIONS, WHILE IN THE MIDDLE OF A SURGICAL CASE, THE DETACHABLE PLASTIC PIECE ON THE TOP OF THE E NDOTRACHEAL TUBE HAS COME OFF COMPLETELY WITH THE CIRCUIT ATTACHED WHILE THE PATIENT IS INTUBATED. LAST WEEK THIS HAPPENED TWICE IN THE MIDDLE OF OUR FIRST CASE." AFTER FURTHER CORRESPONDENCE WITH THE REPORTER, THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS 8040412-2023-00047, 8040412-2023-00025, 8040412-2023-00048, 8040412-2023-00049

  Patient problems: Insufficient Information

  MAUDE report 16272750 ↗
• MalfunctionJan 31, 2023Disconnection; Disconnection

  IT IS REPORTED THAT "ON MULTIPLE OCCASIONS, WHILE IN THE MIDDLE OF A SURGICAL CASE, THE DETACHABLE PLASTIC PIECE ON THE TOP OF THE ENDOTRACHEAL TUBE HAS COME OFF COMPLETELY WITH THE CIRCUIT ATTACHED WHILE THE PATIENT IS INTUBATED. LAST WEEK THIS HAPPENED TWICE IN THE MIDDLE OF OUR FIRST CASE." AFTER FURTHER CORRESPONDENCE WITH THE REPORTER, THE CUSTOMER DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE SPECIFICS OF THE EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. ASSOCIATED MDRS 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00025, 8040412-2023-00048.

  Patient problems: Insufficient Information

  MAUDE report 16272613 ↗
• MalfunctionJan 22, 2023Material Perforation; Material Perforation

  REPORTED EVENT: PHARMACY PERSONNEL REPORTS THAT AN ORAL/NASAL ENDOTRACHEAL TUBE IS RETURNED BECAUSE WHEN IT WAS OPENED FROM THE PRIMARY PACKAGING THE ANESTHESIOLOGIST OBSERVES THAT THE BALLOON IS PERFORATED, SO A NEW CUFF WAS REQUESTED TO CONTINUE WITH THE PROCEDURE, THE PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221770 ↗

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-1887-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
• Z-1960-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
• Z-1852-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
• Z-1962-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
• Z-1964-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
• Z-1885-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
• Z-1893-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
• Z-1958-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050
• Z-1899-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
• Z-1889-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
• 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-1881-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
• Z-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100

…and 19 more.