DeRoyal 81-080416Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00749756045766), received between Oct 17, 2019 and Sep 21, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Entrapment of Device; Difficult to Remove

  Patient problems: Insufficient Information

  MAUDE report 50846103 ↗
• 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 25003051 ↗
• MalfunctionJul 7, 2025Device Dislodged or Dislocated; Unintended Deflation; Device Dislodged or Dislocated; Unintended Deflation

  A USER FACILITY REPORTED, "THE BALLOON DEFLATED ON ITS OWN AND CAME OUT OF THE PATIENT. THE RN TESTED THE BALLOON, AND IT LOOKED LIKE IT HAD A HOLE IN IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411051 ↗
• MalfunctionAug 7, 2024Burst Container or Vessel; Device Dislodged or Dislocated; Gas/Air Leak; Burst Container or Vessel; Device Dislodged or Dislocated; Gas/Air Leak

  CATHETER DISLODGED UPON SURGICAL DRAPE REMOVAL. BALLOON INFLATION PERFORMED WHICH DEMONSTRATED PINHOLE LEAKAGE IN BALLOON, WHICH SUBSEQUENTLY BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928476 ↗
• MalfunctionSep 22, 2021Suction Problem; Material Perforation; Infusion or Flow Problem; Suction Problem; Material Perforation; Infusion or Flow Problem

  THE PATIENT CAME TO THE RECOVERY ROOM WITH A FOLEY CATHETER DRAINING CLEAR AMBER URINE. WHEN THE BLANKETS WERE BEING STRAIGHTENED BY A HEALTH PROFESSIONAL, CATHETER TUBING WAS LEFT ON THE BED. WHEN THE CATHETER TUBING WAS BEING STRAIGHTENED, THE FOLEY BULB FELL OUT OF THE URETHRA. THE BULB WAS NOT INFLATED AND THE NURSE PROCEEDED TO TRY TO INFLATE. THE BULB INFLATED, HOWEVER, THE NEXT MINUTE IT DID NOT STAY INFLATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 12514412 ↗
• MalfunctionJul 2, 2021Suction Problem; Compatibility Problem; Infusion or Flow Problem; Suction Problem; Compatibility Problem; Infusion or Flow Problem

  THE PATIENT RETURNED FROM THE OPERATION ROOM WITH ZERO URINE IN THE FOLEY CATHETER BAG AND THE UROMETER WAS DRY AND COLLAPSED WITHOUT SIGNS OF ANY COLLECTION INSIDE. THE OPERATION ROOM REPORT SHOWED ULTRAFILTRATION OF 2 L FLUID REMOVAL. THE NURSE RECEIVING THE CASE DID TROUBLESHOOTING OF THE CATHETER AND IRRIGATED WITH NO RETURN, ALSO A BLADDER SCAN DISPLAYED FOR 350 ML. BALLOON DEFLATED AND CATHETER CLEANED AND ADVANCED FURTHER INTO BLADDER, BALLOON RE-INFLATED. URINE OUTPUT CONTINUED TO BE LOW OVER THE NEXT 12 HOURS, HOWEVER WAS CLEAR WITH NO CLOTS AND NO FURTHER MANAGEMENT UNTIL PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN THE MORNING AFTER SURGERY. BLADDER SCANNED AGAIN DISPLAYED TO BE RETAINING URINE. FOLEY AGAIN IRRIGATED BUT UNABLE TO FLUSH OR WITHDRAW IRRIGATION FLUID, FOLLOWING WITH FOLEY CATHETER REMOVED. PATIENT INCONTINENT OF URINE. FOLEY CATHETER REMAINED OUT AND PATIENT ABLE TO VOID WITHOUT ISSUE.

  Patient problems: Abdominal Pain; Urinary Incontinence

  MAUDE report 12106759 ↗
• MalfunctionJul 2, 2021Decrease in Suction; Suction Problem; Decrease in Suction; Suction Problem

  PATIENT WAS STARTED ON A LASIX INFUSION DUE TO LOW URINE OUTPUT OVER A FEW HOURS. IN THE FOLLOWING HOURS HER FOLEY CATHETER WAS BYPASSING LARGE AMOUNTS OF URINE, THE NURSE INVESTIGATED THE SYSTEM INCLUDING A BLADDER SCAN. THE BLADDER SCAN WAS FOUND TO HAVE >999 ML. AS PER UNIT PROTOCOL, THE CATHETER WAS IRRIGATED TO RELIEVE ANY OBSTRUCTION BUT NON WERE FOUND. THE CATHETER BALLOON WAS DEFLATED IN PREPARATION FOR REMOVAL AND THE PATIENT WAS RELEASING LARGE VOLUME OF URINE INTO THE BED. FOLLOWING WHICH, A NEW FOLEY WAS INSERTED AND AN ADDITIONAL 1.5L OF URINE WAS COLLECTED. AN ADDITIONAL >1L WAS COLLECTED IN THE FOLLOWING HOUR AS WELL. THE PATIENT WAS SEDATED AND INTUBATED POST OPERATIVELY, HENCE UNABLE TO COMMUNICATE DISCOMFORT ASSOCIATED WITH SIGNIFICANT URINARY RETENTION.

  Patient problems: Unspecified Kidney or Urinary Problem; Urinary Incontinence

  MAUDE report 12106752 ↗
• MalfunctionJun 15, 2021Display or Visual Feedback Problem; Infusion or Flow Problem; Display or Visual Feedback Problem; Infusion or Flow Problem

  DURING DAY ZERO OF POST-OPERATION, THE PATIENT WAS SHOWING WITH NO URINE OUTPUT IN OPERATING ROOM. WHEN ASSESSED BY THE NURSE BY A BLADDER SCANNER HE HAD 350 ML IN HIS BLADDER DESPITE HAVING A FOLEY CATHETER INSITU. THIS WAS IRRIGATED AND URINE CLEAR OF CLOTS CAME OUT. LOW VOLUMES OF URINE CONTINUED TO DRAIN IN THE FOLLOWING 12 HOURS, HOWEVER THE PATIENT WAS EXPERIENCING INCREASING ABDOMINAL PAIN AND URGE TO VOID. WHEN ASSESSED THE CATHETER WAS UNABLE TO IRRIGATE, AND THE BLADDER SCAN SHOWED RESIDUAL URINE IN THE BLADDER. THE FOLEY CATHETER WAS REMOVED AND THE PATIENT WAS INCONTINENT OF LARGE AMOUNTS OF URINE. THIS PATIENT EXPERIENCES SIGNIFICANT AND PAINFUL URINARY RETENTION DESPITE THE CATHETER BEING INSITU.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 11998430 ↗
• MalfunctionJun 11, 2021Display or Visual Feedback Problem; Suction Problem; Infusion or Flow Problem; Display or Visual Feedback Problem; Suction Problem; Infusion or Flow Problem

  DURING DAY THREE OF POST-OPERATION, THE PATIENT WAS SHOWING SIGNS OF LOW URINE OUTPUT, SHE WAS STARTED ON A DIURETIC INFUSION TO FACILITATE FLUID REMOVAL AND DIURESIS. THE FOLEY CATHETER WAS BYPASSING URINE ONTO THE BED, SO THE NURSE ASSESSED THE SYSTEM. THIS INCLUDED A BLADDER SCAN WHICH SHOWED A RETAINED VOLUME OF >999ML IN HER BLADDER DESPITE HAVING A CATHETER INSITU. THE NURSE ATTEMPTED TO IRRIGATE THE FOLEY FOR OBSTRUCTION AND WAS UNSUCCESSFUL. IN FACT THE IRRIGATION FLUID BYPASSED AROUND THE CATHETER AN ONTO THE BED AS WELL. THE BALLOON OF THE FOLEY WAS DEFLATED IN PREPARATION FOR REMOVAL AND THE PATIENT WAS INCONTINENT OF LARGE VOLUMES OF URINE. FOLLOWING THIS, A NEW CATHETER WAS PLACED AND DRAINED 1.5 L OF URINE, AND >1 L IN THE HOUR FOLLOWING. THE PATIENT WAS SEDATED DURING THIS EVENT SO WAS UNABLE TO COMMUNICATE DISCOMFORT OR URGE TO VOID. THIS PATIENT WAS UNNECESSARILY EXPOSED TO HIGH DOSE DIURETICS AND HIGH-VOLUME URINE RETENTION WHICH COULD HAVE CAUSED SIGNIFICANTLY RENAL DYSFUNCTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 11983416 ↗
• MalfunctionMay 20, 2021Suction Problem; Suction Problem

  POST-OP PATIENTS HAVING MULTIPLE ISSUES WITH SIGNIFICANT HEMATURIA, CATHETER OBSTRUCTION AND FOLEY CATHETER DISPLACEMENT CAUSING URINARY RETENTION. UPON REVIEW, THERE ARE CONCERNS RELATED TO MIGRATION OUT OF THE BLADDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Kidney or Urinary Problem

  MAUDE report 11855876 ↗
• MalfunctionOct 17, 2019Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  UNABLE TO DRAW URINE FROM THE CATHETER. THE CATHETER LOOKS LIKE IT IS BLOCKED. THIS OCCURRED DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202211 ↗