RUSCH IPN041701Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704344236), received between Nov 18, 2022 and Jan 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 5, 2026Gas/Air Leak

  IT WAS REPORTED "DURING INTUBATION, TWO DOUBLE-LUMEN TUBES WERE DEFECTIVE, AND THE BRONCHIAL PNEUMATIC PLUG LEAKED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". 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. PLEASE SEE ASSOCIATED MDR#: 8040412-2026-00003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956348 ↗
• MalfunctionJan 5, 2026Gas/Air Leak

  IT WAS REPORTED "DURING INTUBATION, TWO DOUBLE-LUMEN TUBES WERE DEFECTIVE, AND THE BRONCHIAL PNEUMATIC PLUG LEAKED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". 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. PLEASE SEE ASSOCIATED MDR#: 8040412-2026-00004, 8040412-2026-00003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956341 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "WHEN INFLATING THE TRACHEAL CUFF, A LEAK IS OBSERVED, SO THE TREATING PHYSICIAN REMOVES IT AND REPLACED IT WITH A DOUBLE-LUMEN TUBE 35."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451770 ↗
• MalfunctionDec 22, 2022Material Rupture; Material Rupture

  REPORTED ISSUE: PRIOR TO USE, DURING THE TEST OF THE ENDOBRONCHIAL CANNULA, IT WAS NOTICED THAT THE CUFF WAS PERFORATED AND IT WAS NECESSARY TO REPLACE THE PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 16035913 ↗
• MalfunctionNov 18, 2022Inflation Problem; Inflation Problem

  REPORTED ISSUE: BEFORE APPLYING ANESTHESIA, THE SPECIALIST VERIFIED THE BRONCHIAL CUFF BY TRYING TO INFLATE IT AND IT DEFLATED BY ITSELF. AS BEING UNABLE TO SEAL IT HAD TO BE REPLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828405 ↗