RUSCH IPN040783Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704340870), received between Mar 8, 2021 and Mar 15, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

24 other recalls cover devices cleared under the same FDA submission (K961840); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "TUBE SIZE WAS A SIZE 7. ABLE TO INTUBATE PATIENT. AFTER AN HOUR CUSTOMER NOTICED THAT THE CONNECTOR POPS OFF OUR ET TUBE. CONDITION OF PATIENT IS THEY ARE HOME. MEDICAL INTERVENTION WAS NEEDED. PATIENT WAS NOT HARMED OR INJURED. PATIENT DID EXPERIENCE DESATURATION. PROBLEM WAS SOLVED. THEY DID NOT EXTUBATE THEN INTUBATE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 11488000 ↗
• MalfunctionMar 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CLINICIANS ARE ABLE TO INTUBATE THE PATIENT JUST FINE. AFTER AN HOUR THEY NOTICE THAT THE CONNECTOR POPS OFF OUR ET TUBE". NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486333 ↗
• MalfunctionMar 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "SIZE OF THIS ET TUBE WAS A SIZE 7 TUBE. CONDITION OF THE PATIENT IS ON VENT. NO MEDICAL INTERVENTION NEEDED. PATIENT DID NOT EXPERIENCE DESATURATION. PROBLEM WAS SOLVED. THEY DID NOT EXTUBATE OR INTUBATE. CLINICIANS ARE ABLE TO INTUBATE THE PATIENT JUST FINE. AFTER AN HOUR THEY NOTICE THAT THE CONNECTOR POPS OFF OUR ET TUBE". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Ventilator Dependent

  MAUDE report 11486200 ↗
• MalfunctionMar 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CLINICIANS ARE ABLE TO INTUBATE THE PATIENT JUST FINE. AFTER AN HOUR THEY NOTICE THAT THE CONNECTOR POPS OFF OF OUR ET TUBE". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439321 ↗
• MalfunctionMar 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "CLINICIANS ARE ABLE TO INTUBATE THE PATIENT JUST FINE. AFTER AN HOUR THEY NOTICED THAT THE CONNECTOR POPS OFF OF OUR ET TUBE". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439286 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961840. One submission often covers many models, so check the product and lot details in each record.

• Z-1855-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530
• Z-1934-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382025
• Z-1928-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040
• Z-1874-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
• Z-1925-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025
• Z-1939-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065
• Z-1931-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
• Z-1935-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040
• Z-1933-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
• Z-1858-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
• Z-1859-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
• Z-1926-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
• Z-1856-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535
• Z-1932-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
• Z-1875-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035

…and 9 more.