Dover 145516Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521009773), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• MalfunctionApr 30, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THEY HAD AN ISSUE WITH A LEG BAG. THE FOLEY HAD BEEN CLAMPED AFTER INSTILLING INTRAVESICAL CHEMOTHERAPY AND A URINE LEG BAG WAS APPLIED AS PER PROTOCOL. WHEN THE DWELL TIME WAS COMPLETED, THE FOLEY WAS UNCLAMPED BUT THERE WAS NO URINE/CHEMO COMING OUT INTO THE DRAIN BAG. THE PATIENT STOOD UP AND URINE/CHEMO STATED COMING OUT AROUND THE FOLEY, NOT INTO THE LEG BAG. THE FOLEY WAS CLAMPED AGAIN AND THE LEG BAG WAS REPLACED WITH ANOTHER LEG BAG. THIS TIME THE URINE/CHEMO WENT RIGHT INTO THE LEG BAG. THERE WAS NO HARM TO THE PATIENT BUT DISCHARGE WAS DELAYED A FEW HOURS DUE TO DEVICE REPLACEMENT AND CLEAN UP OF THE SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752455 ↗