RUSCH IPN050150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026704308033), received between Oct 28, 2022 and May 19, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT "PATIENT SAID SHE HAS A RASH AND THE CATHETER KEEPS GETTING CLOGGED DUE TO A UTI. PATIENT ALSO SAID THE TUBING KINKS AND FOLDS AND CAUSES BACK FLOW". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE PATIENT WAS HAVING A LOT OF DISCHARGE CAUSING THE CATHETER TO CLOG. THE [DOCTOR] CHANGED THEM TO THIS CATHETER AND THE CATHETER STARTED KINKING AND SEPARATING FROM THE COLLECTION BAG. THE CAREGIVER STATED THAT THE RASH WAS FROM THE OVERFLOW OF URINE NOT DRAINING INTO THE BAG. [THE PATIENT] IS A QUADRIPLEGIC". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Rash

  MAUDE report 16967224 ↗
• MalfunctionOct 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT SHE HAD TWO FOLEY CATHETERS THAT SHE TRIED TO USE BUT BOTH WERE DEFECTIVE IN THE BALLOON AREA. THE FIRST FOLEY DEFLATED IMMEDIATELY AFTER INSERTING IT CAUSING LEAKAGE; THE SECOND FOLEY LASTED ABOUT AN HOUR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692960 ↗
• MalfunctionOct 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT SHE HAD TWO FOLEY CATHETERS THAT SHE TRIED TO USE BUT BOTH WERE DEFECTIVE IN THE BALLOON AREA. THE FIRST FOLEY DEFLATED IMMEDIATELY AFTER INSERTING IT CAUSING LEAKAGE; THE SECOND FOLEY LASTED ABOUT AN HOUR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692441 ↗