RUSCH IPN050148Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704308026), received between May 6, 2022 and Nov 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2022No Flow; No Flow

  REPORTED ISSUE: THE CATHETER HE RECEIVED IS DEFECTIVE. IT WILL NOT OPEN TO RELEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788835 ↗
• MalfunctionMay 6, 2022Burst Container or Vessel; Burst Container or Vessel

  PATIENT CALLED STATING THAT OVER THE WEEKEND HE HAD TWO CATHETERS THAT THE BALLOONS BURST AND THE CATHETER EXPELLED HIS BODY. IN ADDITION TO THE BALLOONS BURSTING, THE MATERIAL IS THIN AND EXTREMELY FLEXIBLE, ALLOWING THE HOSE TO CRIMP EASILY, CAUSING A BLADDER NOT TO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306269 ↗
• MalfunctionMay 6, 2022Burst Container or Vessel; Burst Container or Vessel

  PATIENT CALLED STATING THAT OVER THE WEEKEND HE HAD TWO CATHETERS THAT THE BALLOONS BURST AND THE CATHETER EXPELLED HIS BODY. IN ADDITION TO THE BALLOONS BURSTING, THE MATERIAL IS THIN AND EXTREMELY FLEXIBLE, ALLOWING THE HOSE TO CRIMP EASILY, CAUSING A BLADDER NOT TO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306130 ↗