DeRoyal 81-080418Recalls & reported problems
Deroyal Industries, Inc. · Foley Catheter with Temperature Sensor · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756045759), received between Apr 27, 2026 and Apr 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Blocked Connection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Blocked Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Blocked Connection
A DISTRIBUTING FACILITY REPORTED, "ALL THREE PATIENTS WERE HAVING DECREASE IN URINE OUTPUT, DURING ASSESSMENT THE UCT TEAM REVIEWED THE CASES AND FOUND THAT ALL THREE FOLEY CATHETERS WERE BLOCKED. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003054 ↗
Other CATHETER, UPPER URINARY TRACT devices
- DeRoyal 81-080414EUDeroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT13 reports
- DeRoyal 81-080416EUDeroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT12 reports
- DeRoyal 81-080416Deroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT11 reports
- DeRoyal 81-080408Deroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT10 reports
- DeRoyal 81-080414Deroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT6 reports
- DeRoyal 81-080410Deroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.