RUSCH IPN044694Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704547685), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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

23 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. 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-1856-2023 · Root cause: Under Investigation by firm · 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.

• InjuryAug 31, 2023Break; Break

  IT WAS REPORTED THAT THE "BEDSIDE RN DOING MORNING CARES AND MEDS. PATIENT IS INTUBATED, SEDATED AND PARALYZED IN THE BED. PATIENT STARTED TO [DESATURATE] FROM 98-89%. RN ASSESSED PATIENT, AND VENT SETTINGS, IN PREPPING TO SUCTION PATIENT, RN SAW ETT CONNECTOR WAS BROKEN OFF IN THE BED AND PATIENT QUICKLY [DESATURATED] TO 40%. RN STARTED TO MASK BAG OVER THE ETT @ 100% WHILE CALLING FOR FULL ASSIST, CONTINUING TO BAG. PATIENT WENT INTO FULL CARDIAC ARREST, COMPRESSIONS STARTED". ADDITIONAL INFORMATION STATES, THIS PIECE ACTUALLY BROKE AND THE SMALL PLASTIC PIECE GOT LODGED IN THE AIRWAY CAUSING AN OBSTRUCTION. IT DID NOT DISCONNECT". FURTHER INFORMATION RECEIVED STATES, "UNCERTAIN AS TO HOW IT BROKE, WHILE THE NURSE WAS PROVIDING CARE, FOUND THE BROKEN PIECE IN THE BED. PATIENT WAS HAVING AM CARE DONE". THE CURRENT STATUS OF THE PATIENT IS REPORTED AS "STABLE".

  Patient problems: Airway Obstruction; Cardiac Arrest; Low Oxygen Saturation; Respiratory Arrest

  MAUDE report 17665080 ↗

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-1927-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
• Z-1934-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382025
• Z-1931-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
• Z-1933-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
• Z-1854-2023 · May 25, 2023 · Open, Classified
  Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
• Z-1876-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050
• Z-1939-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382065
• Z-1874-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
• Z-1935-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040
• Z-1938-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060
• Z-1875-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
• Z-1937-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
• Z-1930-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050
• Z-1928-2023 · May 25, 2023 · Open, Classified
  Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040

…and 8 more.