RUSCH IPN050272Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026704335046), received between Apr 24, 2023 and Apr 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionApr 24, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE ON A PATIENT, CATHETER LEAKS WERE FOUND. A BLADDER SCAN SHOWED EVIDENCE OF A HIGH VOLUME OF FLUID ALTHOUGH THE CATHETER WAS IN PLACE. THE BALLOON WAS TESTED BEFORE USE AND THE INFLATION VOLUME RESPECTED. THE LUBRICANT USED WAS OPTILUBE. DURING REMOVAL, THE BALLOON WAS NOT COMPLETELY DEFLATED DESPITE THE REMOVAL OF 10ML OF STERILE WATER THAT HAD BEEN INSERTED THE DAY BEFORE. A PRESENCE OF DEPOSIT ON THE TIP OF THE URINARY CATHETER WAS ALSO REPORTED. AS A RESULT, THE CATHETER WAS REMOVED AND 3-WAY CATHETER WAS INSERTED. NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796009 ↗
• MalfunctionApr 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE ON A PATIENT, CATHETER LEAKS WERE FOUND. A BLADDER SCAN SHOWED EVIDENCE OF A HIGH VOLUME OF FLUID ALTHOUGH THE CATHETER WAS IN PLACE. THE BALLOON WAS TESTED BEFORE USE AND THE INFLATION VOLUME RESPECTED. THE LUBRICANT USED WAS OPTILUBE. DURING REMOVAL, THE BALLOON WAS NOT COMPLETELY DEFLATED DESPITE THE REMOVAL OF 10ML OF STERILE WATER THAT HAD BEEN INSERTED THE DAY BEFORE. A PRESENCE OF DEPOSIT ON THE TIP OF THE URINARY CATHETER WAS ALSO REPORTED. AS A RESULT, THE CATHETER WAS REMOVED AND 3-WAY CATHETER WAS INSERTED. NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795960 ↗