RUSCH IPN041702Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704344243), received between Jun 2, 2022 and Jul 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO USE, "IMPOSSIBLE TO CONNECT THE SYRINGE WITH THE BLUE CUFF, THEREFORE IMPOSSIBLE TO USE." NO PATIENT I INVOLVEMENT. THE ISSUE WAS RESOLVED BY USING A NEW DEVICE OF THE SAME BRAND. NO IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17363311 ↗
• MalfunctionJun 2, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED "CUFF RUPTURE OF THE BRONCHO PART[OF] ENDOTRACHEAL TUBE DURING PATIENT INTUBATION". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14572600 ↗