RUSCH IPN041544Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704341495), received between May 26, 2023 and Jul 1, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K993786); 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-1895-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryJul 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT: PATIENT'S ENDOTRACHEAL TUBE DOES NOT HAVE ANY NUMBERS, THEREFORE WE CAN NOT TELL IF THE ETT IS IN PROPER POSITION. THE PATIENT HAS LARGE AMOUNT ON SECRETIONS. PATIENT ALREADY HAS A HISTORY OF AIRWAY EDEMA ALONG WITH DIFFICULT INTUBATION. UPON XRAY, PATIENT ETT WAS AT THE CLAVICLE. THE MEASURED 1.5CM FROM POSITION OF ETT THEN PUSHED IN 1.5CM WITH NO XRAY TO FOLLOW. LMA'S WERE PLACED AT PATIENT BEDSIDE. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED. ADDITIONA INFORMATION: THE MARKINGS HAD BEEN PRESENT BUT FADED OVER TIME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19643043 ↗
• MalfunctionMay 26, 2023Pumping Problem; Pumping Problem

  THE REPORT STATES "AFTER WE INFLATE THE CUFF AS MUCH AS WE CAN SAFELY, WE CAN STILL HEAR AIR ESCAPING AROUND THE TUBE WHICH SUGGESTS THERE IS NOT AN APPROPRIATE SEAL OF THE TRACHEA. OUR CONCERN WITH THESE ETT IS THAT THEY ARE NOT BEING CORRECTLY INFLATED TO HAVE A SAFE PRESSURE ON THE CAT'S TRACHEAL WALL AND THAT THEY ARE NOT CREATING A TIGHT SEAL WHICH IS ALLOWING ISOFLURANE TO ESCAPE AROUND THE TUBE".

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

  MAUDE report 17011747 ↗
• MalfunctionMay 26, 2023Leak/Splash; Leak/Splash

  THE REPORT STATES "AFTER WE INFLATE THE CUFF AS MUCH AS WE CAN SAFELY, WE CAN STILL HEAR AIR ESCAPING AROUND THE TUBE WHICH SUGGESTS THERE IS NOT AN APPROPRIATE SEAL OF THE TRACHEA. OUR CONCERN WITH THESE ETT IS THAT THEY ARE NOT BEING CORRECTLY INFLATED TO HAVE A SAFE PRESSURE ON THE CAT'S TRACHEAL WALL AND THAT THEY ARE NOT CREATING A TIGHT SEAL WHICH IS ALLOWING ISOFLURANE TO ESCAPE AROUND THE TUBE".

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

  MAUDE report 17011711 ↗
• MalfunctionMay 26, 2023Pumping Problem; Pumping Problem

  THE REPORT STATES "AFTER WE INFLATE THE CUFF AS MUCH AS WE CAN SAFELY, WE CAN STILL HEAR AIR ESCAPING AROUND THE TUBE WHICH SUGGESTS THERE IS NOT AN APPROPRIATE SEAL OF THE TRACHEA. OUR CONCERN WITH THESE ETT IS THAT THEY ARE NOT BEING CORRECTLY INFLATED TO HAVE A SAFE PRESSURE ON THE CAT'S TRACHEAL WALL AND THAT THEY ARE NOT CREATING A TIGHT SEAL WHICH IS ALLOWING ISOFLURANE TO ESCAPE AROUND THE TUBE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

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

  MAUDE report 17011672 ↗
• MalfunctionMay 26, 2023Leak/Splash; Leak/Splash

  THE REPORT STATES "AFTER WE INFLATE THE CUFF AS MUCH AS WE CAN SAFELY, WE CAN STILL HEAR AIR ESCAPING AROUND THE TUBE WHICH SUGGESTS THERE IS NOT AN APPROPRIATE SEAL OF THE TRACHEA. OUR CONCERN WITH THESE ETT IS THAT THEY ARE NOT BEING CORRECTLY INFLATED TO HAVE A SAFE PRESSURE ON THE CAT'S TRACHEAL WALL AND THAT THEY ARE NOT CREATING A TIGHT SEAL WHICH IS ALLOWING ISOFLURANE TO ESCAPE AROUND THE TUBE".

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

  MAUDE report 17011655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993786. One submission often covers many models, so check the product and lot details in each record.

• Z-1898-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
• Z-1896-2023 · May 25, 2023 · Open, Classified
  RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030