Medline URO170350ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889942467143), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Contaminated During Manufacture or Shipping

  It was reported that ¿while RN was inserting a foley for the procedure, debris was noted to be in the sterile water provided in the Medline Add-A-Cath. It was noticed prior to inflating the balloon and was replaced with sterile water from the Omnicell and a new sterile syringe.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952529 ↗