RUSCH IPN041503Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704341433), received between Jan 31, 2023 and Apr 14, 2026 — classified as 4 malfunctions.

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-1889-2023 · 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: "CONNECTOR ON ET TUBES NOT STAYING ON WHEN CONNECTED TO CIRCUITS. THERE WAS NO REPORTED PATIENT HARM." PLEASE NOTE THAT THIS COMPLAINT IS IN RELATION TO 10 DEVICES OF THE SAME LOT# REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873382 ↗
• MalfunctionAug 21, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE PATIENT WAS INTUBATED, THE DOCTOR INFLATED THE BALLOON AND REALIZED THAT THE BALLOON WAS DEFLATING AND DECIDED TO REMOVE THE TUBE AND PLACE ANOTHER ONE." PER THE CUSTOMER, IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, DESATURATION OR INJURY OR THE PATIENT'S CURRENT STATUS. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17586326 ↗
• MalfunctionMar 30, 2023Deflation Problem; Deflation Problem

  REPORTED ISSUE: WHILE THE ENDOTRACHEAL TUBE WAS BEING USED IT WAS NOT POSSIBLE TO DEFLATE THE BALLOON DISCONNECTING LINE. IT WAS REMOVED FROM THE PATIENT WITH THE BALLOON STILL INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648685 ↗
• 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 040412-2023-00046, 8040412-2023-00025, 8040412-2023-00048, 8040412-2023-00049.

  Patient problems: Insufficient Information

  MAUDE report 16272732 ↗

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-1961-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
• Z-1959-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
• 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-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
• 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-1960-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
• 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-1964-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1888-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
• Z-1886-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
• Z-1884-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050

…and 19 more.