Medline UROT1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489491081), received between Jun 28, 2022 and Sep 17, 2026 — classified as 3 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 18, 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.

• MalfunctionSep 17, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that "the foley bag was leaking urine. There was a small hole in the lower left corner of the foley bag."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804735 ↗
• MalfunctionSep 8, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

  It was reported that "RN was drawing clean catch urine sample off of foley catheter, and when RN disconnected the syringe, the foley sampling port came off of the catheter tubing".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671287 ↗
• MalfunctionJun 28, 2022Break

  IT WAS REPORTED BY THE FACILITY THAT THE FOLEY CATHETER BALLOON BROKE ON INFLATION WHILE IN THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14848822 ↗