RUSCH IPN050127Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026704307975), received between May 10, 2021 and Dec 10, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2022Deflation Problem; Deflation Problem

  REPORTED ISSUE: A BALLOON CATHETER WOULD NOT DEFLATE EVEN THOUGH IT HAD BEEN TESTED BEFORE THE PROCEDURE. THIS IS THE FIRST TIME THIS HAS EVER HAPPENED AT THE CLINIC. IT CAUSED DISTRESS AND DISSATISFACTION FOR OUR CLIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956149 ↗
• MalfunctionMay 10, 2021Break; Break

  THE CATHETER WAS INSTALLED IN THE PATIENT FOR MORE THAN 24 HOURS, WHEN IT WAS UNEXPECTEDLY CUT FROM THE JUNCTION OF THE LINES WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797078 ↗