Medline URO180716Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942687084), received between Dec 17, 2020 and May 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE CUSTOMER, ON 04/09/2024 THE FOLEY BALLOON DID NOT INFLATE REQUIRING AN ADDITIONAL CATHETER TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271954 ↗
• InjuryDec 2, 2021Material Rupture

  IT WAS REPORTED THAT DURING AN IMAGING PROCEDURE THE FOLEY CATHETER BALLOON RUPTURED WHILE INSERTED IN THE PATIENT WHILE THE BALLOON WAS BEING FILLED. THE PROCEDURE WAS STOPPED AND THE SYSTEM WAS RECONNECTED TO THE BAG. CONTRAST AND BLOOD WAS OBSERVED IN THE BAG. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12915947 ↗
• MalfunctionDec 17, 2020Defective Component; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED, TWO SILICONE 1- LAYER FOLEY CATHETER WITH DRAIN BAG'S HAD DEFECTIVE BULBS. CATHETERS HAD BEEN INSERTED, BULBS INFLATED AND EACH TIME THE CATHETERS FELL OUT AND THE BULBS WERE NOT INFLATED. THIRD ATTEMPT WITH NEW CATHETER WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032225 ↗