DeRoyal 81-080416EURecalls & reported problems
Deroyal Industries, Inc. · Foley Catheter with Temperature Sensor · Class 2
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00749756596664), received between Dec 1, 2020 and Dec 16, 2025 — classified as 8 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow7
- Material Integrity Problem3
- Material Rupture3
- Decrease in Suction1
- Device Dislodged or Dislocated1
- Infusion or Flow Problem1
- Unintended Deflation1
Patient problems
- Urinary Retention9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Tissue Irritation1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Device Dislodged or Dislocated; Unintended Deflation; Device Dislodged or Dislocated; Unintended Deflation
A USER FACILITY REPORTED, "THE NEED TO REPLACE THREE BLADDER CATHETERS WITH THERMISTOR CH16 REF 81-080416EU IS REPORTED DUE TO REPEATED DEFLATION OF THE BALLOON AND CONSEQUENT DISPLACEMENT OF THE CATHETER. IN ALL CASES, THE CATHETER WAS FOUND OUT OF PLACE WITH THE BALLOON DEFLATED. IT SHOULD BE NOTED THAT THE PROBLEM OCCURRED WITH ONLY ONE PATIENT AND THAT HIM WAS LATER DISCOVERED WITH A URETHRAL STONE, THUS RAISING THE QUESTION OF A CORRELATION WITH THE EVENT THAT OCCURRED."
Patient problems: Tissue Irritation
MAUDE report 23817646 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19932604 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19932533 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19931712 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19931698 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19931691 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19931672 ↗InjuryAug 7, 2024Obstruction of Flow; Obstruction of Flow
THE CATHETERS CLOGGED EVERY TIME WHERE THE PATIENT GETS A PROPER BLADDER RETENTION WITH ALL ITS CONSEQUENCES. IT SEEMS THAT THIS IS RELATED TO THE BALLOON CHANGE.
Patient problems: Urinary Retention
MAUDE report 19931662 ↗MalfunctionMay 13, 2021Decrease in Suction; Infusion or Flow Problem; Decrease in Suction; Infusion or Flow Problem
UNABLE TO WITHDRAW REMAINING FLUID FROM THE CATHETER. MORE FLUID COULD BE INSERTED INTO THE BALLOON BUT NOT REMOVED. BALLOON REMAINED INFLATED WHEN WITHDRAWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11821153 ↗MalfunctionDec 1, 2020Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem
A 16 FRENCH FOLEY CATHETER RUPTURED DURING USE ON A PATIENT.
Patient problems: Urinary Retention
MAUDE report 10930564 ↗MalfunctionDec 1, 2020Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem
A 16 FRENCH FOLEY CATHETER RUPTURED WHILE PLACED IN A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10930523 ↗MalfunctionDec 1, 2020Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem
A 16 FRENCH FOLEY CATHETER RUPTURED DURING USE ON A PATIENT.
Patient problems: Urinary Retention
MAUDE report 10930498 ↗
Other CATHETER, UPPER URINARY TRACT devices
- DeRoyal 81-080414EUDeroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT13 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
- DeRoyal 81-080418Deroyal Industries, Inc. · CATHETER, UPPER URINARY TRACT1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.