DeRoyal 81-080414Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00749756045773), received between Aug 5, 2020 and Apr 27, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 25003058 ↗
• InjuryApr 23, 2026Insufficient Device Problem Information

  A DISTRIBUTING FACILITY REPORTED, "THE HOSPITAL REPORTED AN INCIDENT INVOLVING THE PATIENT NAMED ABOVE, WHO UNDERWENT SURGERY ON (B)(6) 2026, PERFORMED BY (B)(6). A FOLEY CATHETER WITH A TEMPERATURE PROBE WAS PLACED IN SITU PRE-SURGERY, TOGETHER WITH ALL OTHER INTRA-VASCULAR LINES. A PATIENT PLATE WAS PLACED ON THE PATIENT'S LOWER BACK. IT WAS REPORTED THAT ONCE THE SURGERY WAS COMPLETED AND THE DRAPES WERE REMOVED, THE OPERATING ROOM STAFF DISCOVERED THAT THE PATIENT HAD SUSTAINED A SECOND[?]DEGREE BURN INJURY DURING THE PROCEDURE. THE BURN INJURY WAS IDENTIFIED ON THE PATIENT'S PENIS AND SCROTUM. THE FOLEY CATHETER REMAINED IN SITU, AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL ICU, WHERE TREATMENT CONTINUED FOR BOTH THE SURGICAL PROCEDURE AND THE BURN INJURIES. THE INCIDENT WAS FORMALLY REPORTED, AND THE ANAESTHETIST REQUESTED AN INVESTIGATION INTO THE MATTER. THE PATIENT WAS DISCHARGED FROM SURGICAL ICU AND TRANSFERRED TO A GENERAL WARD ON (B)(6) 2026."

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24971932 ↗
• MalfunctionNov 6, 2025Burst Container or Vessel; Burst Container or Vessel

  A DISTRIBUTING FACILITY REPORTED, "IT WAS NOTICED AFTER THE SURGERY THAT THE FOLEY CATHETER WAS NOT IN THE PATIENT, THAT THE BALLOON HAD BURST. NO BLOOD WAS NOTED. 300ML OF CLEAR YELLOW URINE WAS DRAINED IN THE FOLEY BAG. SURGEON AND ANESTHESIOLOGIST THERE WERE NOTIFIED OF THE INCIDENT. UNSURE IF THERE WAS AN INJURY IN THE URETHRA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487990 ↗
• MalfunctionJul 7, 2025Blocked Connection; Blocked Connection

  A USER FACILITY REPORTED, "THERE WAS NO URINE OUTPUT FOR 6 HOURS AFTER LASIX ADMINISTRATION. NOTED PALPABLE BLADDER AND BLADDER SCAN WAS DONE. FOLEY CATHETER WAS CHANGED AND 1100ML OF URINE WAS DRAINED."

  Patient problems: Urinary Retention

  MAUDE report 22411050 ↗
• MalfunctionMay 13, 2021Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation

  FOLEY CATHETER HAD SLIPPED OUT AND WAS DRAINING ONTO THE FLOOR. UPON INSPECTION OF THE BALLOON CUFF, THERE WAS A 1-2 CM HOLE IN THE FOLEY CATHETER BALLOON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11821206 ↗
• MalfunctionAug 5, 2020Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  CATHETER WAS INSERTED INTO THE PATIENT. ON INSERTING WATER INTO THE RETENTION BALLOON, THE FLUID WAS OBSERVED LEAKING FROM THE URETHRAL MEATUS AND THE CATHETER SLID OUT. ON TESTING AFTER REMOVAL, THE CATHETER WAS SEEN TO HAVE A LEAK IN THE BALLOON. 10MLS OF WATER WAS USED. IT WAS NOT INSERTED INTO THE CATHETER WITH ANY FORCE, AND THERE WAS NO RESISTANCE. PROCEDURE WAS DELAYED AS ANOTHER CATHETER HAD TO BE INSERTED TO CONTINUE WITH THE PROCEDURE. THE CATHETER WAS BEING INSERTED INTO THE PATIENT TO USE AS A TEMPERATURE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10367699 ↗