Medline URO170812Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942213481), received between Oct 17, 2023 and Apr 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE LEAKED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046560 ↗
• InjuryOct 17, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 THERE WAS NO "TAPE ON CONNECTION" AND THE FOLEY WAS DISCONNECTED FROM THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952596 ↗