Medline URO180816Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10889942687145), received between May 1, 2019 and Sep 14, 2026 — classified as 5 injuries, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763587 ↗
• InjuryDec 6, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE FOLEY WAS INSERTED, BUT THE BALLOON "WOULD NOT INFLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865378 ↗
• MalfunctionAug 25, 2021Material Rupture

  IT WAS REPORTED THAT THE URINARY CATHETER BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365158 ↗
• InjuryJul 3, 2020Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT HAD PROSTATECTOMY PROCEDURE, DISCHARGED HOME WITH A JP DRAIN AND URINARY CATHETER. PATIENT EXPERIENCED LARGE URINE LEAK FROM THE CATHETER AT HOME. FOLLOWED-UP WITH MD (DATE UNKNOWN), CATHETER CHANGED AND CT SCAN COMPLETED TO CONFIRM PLACEMENT. PATIENT AGAIN DISCHARGED HOME FROM CLINIC TO BE ADMITTED TO UNITY POINT-ROCK ISLAND HOSPITAL (DATE UNKNOWN). IT WAS REPORTED CULTURES WERE (B)(6) FOR BLOOD IN BOTH THE URINE AND JP DRAIN.

  Patient problems: Unspecified Infection

  MAUDE report 10230751 ↗
• InjuryJul 3, 2020Complete Blockage; Coagulation in Device or Device Ingredient

  IT WAS REPORTED A PATIENT HAD A PROSTATECTOMY ON (B)(6) 2020. PATIENT WAS SEEN BY PHYSICIAN AS AN OUTPATIENT (DATE UNKNOWN), DUE TO COMPLAINTS OF NO URINE OUTPUT AND BLADDER DISTENTION. REPORTEDLY, THE CATHETER HAD CLOTTED AND DISRUPTED THE ANASTOMOSIS. A DRAIN WAS PLACED BY INTERVENTIONAL RADIOLOGY (DATE UNKNOWN) AND PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR AN ILEUS (DATE UNKNOWN).

  Patient problems: Local Reaction

  MAUDE report 10228391 ↗
• InjuryMay 1, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOLEY CATHETER BROKE OFF AND HAD TO BE SURGICALLY REMOVED.

  Patient problems: No Information

  MAUDE report 8569166 ↗
• InjuryMay 1, 2019Deflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF THE PATIENT PARTIALLY DEFLATED AND CAUSED UNSPECIFIED TRAUMA.

  Patient problems: No Information

  MAUDE report 8569045 ↗