DeRoyal 81-080414EURecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00749756596657), received between Dec 1, 2020 and Jul 28, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (10 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  A DISTRIBUTING FACILITY REPORTED, "CATHETER BALLOON LEAKS AND DEFLATES NEAR BAG CONNECTION POINT." THE DISTRIBUTED FOLLOWED UP AND STATED NO INJURIES OR OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629928 ↗
• MalfunctionJul 28, 2025Burst Container or Vessel; Burst Container or Vessel

  A DISTRIBUTING FACILITY REPORTED, "WE ONLY RECEIVED NOTIFICATION OF BALLOON BURSTING AS THERE IS NO MENTION OF ACTUAL PROCEDURE TAKING PLACE." THE DISTRIBUTED FOLLOWED UP AND STATED NO INJURIES OR OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629807 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE. 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. 4 URINARY CATHETERS THAT LE

  Patient problems: Urinary Retention

  MAUDE report 19927899 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  A USER FACILITY COMPLAINT WAS RECEIVED ON 07/28/2022 REPORTING "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLA

  Patient problems: Urinary Retention

  MAUDE report 19927897 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. · 4 URINARY CATHETERS THA

  Patient problems: Urinary Retention

  MAUDE report 19927896 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. · 4 URINARY CATHETERS THA

  Patient problems: Urinary Retention

  MAUDE report 19927894 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. · 4 URINARY CATHETERS THA

  Patient problems: Urinary Retention

  MAUDE report 19927893 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. 4 URINARY CATHETERS THAT LE

  Patient problems: Urinary Retention

  MAUDE report 19927890 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. · 4 URINARY CATHETERS THA

  Patient problems: Urinary Retention

  MAUDE report 19927889 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE: 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. 4 URINARY CATHETERS THAT LE

  Patient problems: Urinary Retention

  MAUDE report 19927888 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. · 4 URINARY CATHETERS THA

  Patient problems: Urinary Retention

  MAUDE report 19927887 ↗
• MalfunctionAug 7, 2024Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion; Complete Blockage; Fluid/Blood Leak; Device Dislodged or Dislocated; Expulsion

  "IN THE PAST FEW WEEKS, I HAD 2 PATIENTS WITH A RETENTION BLADDER (1X 800CC). ALL 2 OF THESE PATIENTS CAME FROM THE OR AND HAD BEEN IN THE WARD FOR SEVERAL HOURS. BECAUSE THE URINE PRODUCTION PER HOUR WAS LOW, THEY WERE BOTH FILLED SEVERAL TIMES. IN THE LATE SHIFT I FOUND OUT THAT THE BLADDER WAS FULL. WHEN RINSING, THE LIQUID GOES IN EASILY BUT DOES NOT COME OUT. PATIENTS OFTEN INDICATE THAT THEY HAVE THE FEELING THAT THEY HAVE TO AND CLEARLY HAVE A HARDER TIME. WHEN ASKING AROUND, MORE COLLEAGUES NOTICED THIS. I WAS ABLE TO SOLVE IT EVERY TIME BY EMPTYING THE BALLOON AND MOVING IT FURTHER. PREVIOUSLY WE DID 10CC IN THE DECORATION BUT NOWADAYS THERE IS MAX 5CC IN IT, MAYBE THIS IS THE PROBLEM? I HAVE AN AWAKE PATIENT THIS NIGHT WHO HAS THE SENSATION OF A FULL BLADDER AND LESS URINATION (NO RETENTION BLADDER YET). I HAVE NOW ALSO EMPTIED THE BALLOON AND PUSHED THE CATHETER ON, LATER THE PROBLEM HAS BEEN SOLVED, BUT THAT'S WHY I'M GOING TO DIM IT NOW' AFTER ASKING AROUND AT THE OTHER IC'S IN ONE HALF-DAY (WE HAVE 3) WE COME TO TELL THE NEXT ONE; · 3 COLLEAGUE CASE HISTORIES WHERE THE PATIENT HAD ENCOUNTERED RETENTION BLADDER WITH DEROYAL'S URINARY CATHETER. · 4 URINARY CATHETERS THA

  Patient problems: Urinary Retention

  MAUDE report 19927563 ↗
• MalfunctionDec 1, 2020Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  A 14 FRENCH FOLEY CATHETER WAS PLACED (B)(6). THE BALLOON RUPTURED (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10930543 ↗