RUSCH IPN041459Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04026704325658), received between Apr 2, 2024 and Aug 12, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225570 ↗
• MalfunctionMay 18, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "TODAY WE EXPERIENCED PROBLEMS WITH CUFF LEAKAGE ON 2 TUBES OF THE SAME SIZE. WE UNDERSTAND THAT THIS CAN OCCUR DURING NASAL INTUBATION, BUT WE WERE SURPRISED THAT IT HAPPENED TWICE IN A ROW WITH THE SAME PATIENT AND BATCH. MY COLLEAGUE TESTED THE CUFFS OF BOTH TUBES BEFORE INTUBATION ACCORDING TO ROUTINE, AND SHE DESCRIBES IT AS WHEN SHE INFLATED THE CUFF, THERE WAS NO RESISTANCE. WE CHECKED THE LEAKAGE AFTERWARDS AND FOUND HOLES IN THE SAME LOCATIONS ON BOTH TUBES, IN THE UPPER PART OF THE CUFF." ADDITIONAL INFORMATION RECEIVED ON MAY 12, 2026, INDICATED THAT "WE REALISED THAT THE CUFF OF THE TUBE WAS NOT HOLDING TIGHT WHEN TRYING TO CUFF THE TUBES CUFF, MOMENTA DEFLATION, SO WE REMOVED THE DEFECT TUBE, AND A NEW ONE WAS TESTED. THE DEFECT TUBE WAS NEVER IN USE PRE-SURGERY AND NEVER CONNECTED TO THE RESPIRATOR. THE 3RD TUBE WE USED WORKED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT STATUS IS REPORTED AS "FINE." TWO DEVICES REPORTED. ASSOCIATED MDRS: 8040412-2026-00074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210854 ↗
• MalfunctionMay 18, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT "TODAY WE EXPERIENCED PROBLEMS WITH CUFF LEAKAGE ON 2 TUBES OF THE SAME SIZE. WE UNDERSTAND THAT THIS CAN OCCUR DURING NASAL INTUBATION, BUT WE WERE SURPRISED THAT IT HAPPENED TWICE IN A ROW WITH THE SAME PATIENT AND BATCH. MY COLLEAGUE TESTED THE CUFFS OF BOTH TUBES BEFORE INTUBATION ACCORDING TO ROUTINE, AND SHE DESCRIBES IT AS WHEN SHE INFLATED THE CUFF, THERE WAS NO RESISTANCE. WE CHECKED THE LEAKAGE AFTERWARDS AND FOUND HOLES IN THE SAME LOCATIONS ON BOTH TUBES, IN THE UPPER PART OF THE CUFF." ADDITIONAL INFORMATION RECEIVED ON MAY 12, 2026, INDICATED THAT "WE REALISED THAT THE CUFF OF THE TUBE WAS NOT HOLDING TIGHT WHEN TRYING TO CUFF THE TUBE'S CUFF, MOMENTAN DEFLATION, SO WE REMOVED THE DEFECTIVE TUBE, AND A NEW ONE WAS TESTED. THE DEFECT TUBE WAS NEVER IN USE PRE-SURGERY AND NEVER CONNECTED TO THE RESPIRATOR. THE 3RD TUBE WE USED WORKED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE." TWO DEVICES REPORTED. ASSOCIATED MDRS: 8040412-2026-00074.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210773 ↗
• MalfunctionMay 13, 2026Gas/Air Leak

  IT WAS REPORTED THAT "AFTER INTUBATION INTO THE PATIENT. FOUND CUFF LEAK. THE DOCTOR REMOVED IT AND PLACED A NEW ETT." ADDITIONAL INFORMATION RECEIVED ON APRIL 21, 2026, INDICATED THAT "AFTER PLACEMENT, THE LEAK WAS DETECTED DURING VENTILATION, AND THE ETT WAS REPLACED. THE PATIENT DID NOT HAVE DESATURATION DUE TO THE DEFECT. THE DEVICE WAS PRE-TESTED ACCORDING TO THE IFU. THE PATIENT IS STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165182 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF COULD NOT BE INFLATED DURING THE INFLATION SYSTEM TEST.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635871 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF COULD NOT BE INFLATED DURING THE INFLATION SYSTEM TEST".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628685 ↗
• MalfunctionMay 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT: "UPON INSPECTION AND PRIOR TO USE IT WAS NOTICED THAT THE CUFF WOULD NOT INFLATE DUE TO THERE BEING A HOLE IN THE CUFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094647 ↗
• MalfunctionApr 23, 2025Crack; Crack

  IT WAS REPORTED THAT: "CUFF PASS THE PRE-TEST. HOWEVER, CUFF WAS FOUND CRACKED AFTER INTUBATION. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21888266 ↗
• MalfunctionMar 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT " UPON INSPECTION AND PRIOR TO USE IT WAS NOTICED THAT THE CUFF WOULD NOT INFLATE. MOISTURE WAS ALSO OBSERVED IN THE CUFF AND CUFF PILOT TUBE." ASSOCIATED COMPLAINTS 8040412-2025-00086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696630 ↗
• MalfunctionMar 26, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "UPON INSPECTION AND PRIOR TO USE IT WAS NOTICED THAT THE CUFF WOULD NOT INFLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696566 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT "THE INFLATION LINE WAS FOUNDED BROKEN DURING THE TEST". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266165 ↗
• MalfunctionJul 22, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED "PRIOR TO USE & TEST THE CUFF COULD NOT INFLATE (CUFF LEAKAGE)". THERE WAS NO PAITENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790544 ↗
• MalfunctionApr 2, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT: INCIDENT OCCURRED ON 01 MARCH 2024. A PUNCTURE IN THE CUFF WAS NOTICED DURING ANESTHETIC INDUCTION. THE SAME INCIDENT WAS OBSERVED TWICE IN A ROW WITH TWO DIFFERENT TUBES. IN THE END, THE PATIENT WAS INTUBATED WITH A DIFFERENT TUBE. THERE WAS NO REPORTED PATIENT HARM. ASSOCIATED COMPLAINTS: 8040412-2024-00092.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017854 ↗
• MalfunctionApr 2, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT: INCIDENT OCCURRED ON (B)(6) 2024. A PUNCTURE IN THE CUFF WAS NOTICED DURING ANESTHETIC INDUCTION. THE SAME INCIDENT WAS OBSERVED TWICE IN A ROW WITH TWO DIFFERENT TUBES. IN THE END, THE PATIENT WAS INTUBATED WITH A DIFFERENT TUBE. THERE WAS NO REPORTED PATIENT HARM. ASSOCIATED COMPLAINTS: 8040412-2024-00093.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017666 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED "PRIOR TO USE & INSPECTION, FOUND CUFF LINE BROKEN." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017489 ↗