RUSCH IPN044686Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04026704547623), received between Jan 4, 2023 and Nov 20, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

35 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-1850-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "HOSPITAL STATED PRODUCT WITH SEVER KINKING IN OROPHARYNX RESULTING IN SEVERE ELEVATION IN AIRWAY PRESSURE AND HEMODYNAMIC CHANGES IN THE PATIENT. THE ETT HAD TO BE EXCHANGED IN THE MIDDLE OF AN ONGOING SURGICAL PROCEDURE, SINCE THE KIND WAS NOT REVERSIBLE".

  Patient problems: Airway Obstruction

  MAUDE report 23602534 ↗
• MalfunctionOct 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "PATIENT WAS INTUBATED WITH A 7.5 ETT RUSCH (504575), THEN FLIPPED PRONE. MIDWAY THROUGH THE CASE, ANESTHESIA EXPERIENCED DIFFICULTIES WITH THE PATIENT'S AIRWAY FROM MONITORING DEVICES. THE DECISION WAS MADE TO FLIP THE PATIENT BACK TO SUPINE AND STILL EXPERIENCED DIFFICULTY WITH PATIENTS' AIRWAY. DECISION WAS MADE TO RE-INTUBATED PATIENT WITH A REINFORCED ETT. THE TUBE THAT HAD PREVIOUSLY PLACED WAS REMOVED: A VISIBLE KINK IN THE TUBE WAS DETERMINED TO HAVE OBSTRUCTED THE FLOW OF GASES THROUGH THE CIRCUIT. UNFORTUNATELY, WE DO NOT HAVE THE TUBE THAT WAS INITIALLY USED BUT DO HAVE LOT#. A GOOSE NECK ADAPTER HAD BEEN ATTACHED BETWEEN THE ETT AND THE ELBOW OF THE CIRCUIT. THERE WAS NO PATIENT INJURY OR CONSEQUENCE."

  Patient problems: Airway Obstruction

  MAUDE report 23252544 ↗
• MalfunctionJul 16, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT "AFTER INSERTING IN THE PATIENT, THEY TRIED TO INFLATE AND THE TUBE FAILED. IT APPEARED TO HAVE A LEAK. THERE WAS A HOLE IN IT. PATIENT HAD TO BE EXTUBATED AND RE INTUBATED."

  Patient problems: Insufficient Information

  MAUDE report 22518093 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-20 24-00065, 8040412-2024-00066, 8040412-2024-00067, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711704 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709815 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-20 24-00065, 8040412-2024-00066, 8040412-2024-00067, AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709792 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-2024-00065, 8040412-2024-00066, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709776 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-20 24-00065, 8040412-2024-00067, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709767 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-2024-00066, 8040412-2024-00067, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709418 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-20 24-00065, 8040412-2024-00066, 8040412-2024-00067, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709404 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00061 , 8040412-2024-00063, 8040412-2024-00064, 8040412-2024-00065, 8040412-2024-00066, 8040412-2024-00067, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709387 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. THIS DOES NOT HAPPEN IMMEDIATELY BUT NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST. THE END USER THEN REMOVES THE ORIGINAL CONNECTOR AND REPLACES WITH A 1/2 SIZE LARGER ETT NEW CONNECTOR WHICH SEEMS TO ALLEVIATE THE CONNECTION SEPARATION. ASSOCIATED COMPLAINTS 8040412-2024-00026, 8040412-2024-00062, 8040412-2024-00063, 8040412-2024-00064, 8040412-20 24-00065, 8040412-2024-00066, 8040412-2024-00067, 8040412-2024-00068 AND 8040412-2024-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709341 ↗
• MalfunctionFeb 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "THE END CONNECTOR ON THE ETT BECOMES SEPARATED FROM THE ETT TUBE ITSELF WHEN ATTACHED TO A VENT CIRCUIT. NOTICED IT OCCURS WHEN THE TUBE IS WARM AND MOIST." THE ORIGINAL CONNECTOR WAS REMOVED AND REPLACED WITH A LARGER CONNECTOR. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658436 ↗
• MalfunctionJan 4, 2023Connection Problem; Connection Problem

  REPORTED ISSUE: PILOT BALLOON FOUND TO BE OUT OF ETT. IT IS NOT CLEAR IF IT WAS PULLED OR BIT OFF. NO ALARMS ON THE VENTILATOR WERE ACTIVATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099108 ↗

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-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-1881-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055
• Z-1886-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
• Z-1965-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
• Z-1892-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
• Z-1891-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
• Z-1894-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
• Z-1845-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550
• Z-1853-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
• Z-1885-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
• Z-1888-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
• 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

…and 20 more.