RUSCH IPN050616Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704303943), received between Oct 27, 2021 and Oct 28, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Fell” (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.

• MalfunctionOct 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS 2ND CATHETER USED FOR SAME PATIENT. CATHETER WAS PLACED AFTER INITIAL CATHETER SLID OUT OF PATIENT IN RECOVERY FROM BLADDER TUMOR REMOVAL SURGERY. WHEN NURSE TRIED TO REMOVE THIS CATHETER AFTER 24 HOURS SHE FOUND THAT IT HAD NOT RETAINED THE STERILE WATER IN THE RETENTION BALLOON. CATHETER WAS STILL IN PLACE AND FUNCTIONING PROPERLY BUT BALLOON HAD FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712216 ↗
• MalfunctionOct 27, 2021Device Fell; Device Fell

  CATHETER WAS INSERTED DURING SURGERY TO REMOVE BLADDER TUMOR. WHEN PATIENT WAS MOVED TO INPATIENT RECOVERY THE CATHETER SLID OUT. NO PATIENT HARM OR DISCOMFORT; CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704276 ↗