Irrigation Set 654401Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887787006732), received between Oct 14, 2019 and Mar 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Particulates” (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.

• MalfunctionMar 25, 2020Break; Particulates; Break; Particulates

  THE EVENT INVOLVED A LTXFR CYSTOSCOPY IRR WHERE THE PRONG OF THE CONTINUOUS BLADDER IRRIGATION TUBING SET BROKE OFF AFTER THE BAG WAS SPIKED AND THE PRONG WAS SEEN FLOATING IN THE FLUID OF THE BAG. THERE WAS PATIENT INVOLVEMENT, BUT THE BROKEN PRONG WAS NOTICED AND THE TUBING OR BAG CHANGED OUT BEFORE IT REACHED THE PATIENT. THERE WERE NO FRAGMENTS PASSING THROUGH THE TUBING SET. THERE WAS NO ADVERSE EVENT, NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880194 ↗
• MalfunctionOct 14, 2019Particulates; Particulates

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A LATEX FREE CYSTOSCOPY IRRIGATION SET THAT WAS REPORTED TO HAVE A HAIR INSIDE OF THE TUBING NOTED WHILE STILL IN THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9184506 ↗