Medline UROT1048Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277775848), received between Apr 5, 2023 and Apr 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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.

• MalfunctionApr 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CATHETER FELL OUT REQUIRING REPLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683244 ↗
• MalfunctionApr 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CATHETER FELL OUT REQUIRING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682397 ↗