Medline DYND11003Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10080196991471), received between Aug 30, 2018 and Sep 24, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported that "The catheters are all leaking."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884246 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that "Product consistently leaking, possibly from metal clamp on drainage bags".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856416 ↗
• InjuryMay 5, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE FACILITY, A RESIDENT REQUIRED CATHETER CHANGES DUE TO DEFECTIVE DRAINAGE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959822 ↗
• InjuryApr 24, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE FACILITY ON 4/2, A RESIDENT REQUIRED CATHETER CHANGES DUE TO DEFECTIVE DRAINAGE BAGS. THE BAG WAS NOTED TO BE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904096 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE END USER EXPERIENCED A URINARY TRACT INFECTION (UTI) AND WAS HOSPITALIZED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 13001776 ↗
• MalfunctionAug 10, 2021Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINARY CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300494 ↗
• MalfunctionAug 9, 2021Leak/Splash

  IT WAS REPORTED THAT THE URINARY CATHETER LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298825 ↗
• MalfunctionApr 5, 2021Fluid/Blood Leak

  IT WAS REPORTED, "CATHETER WAS LEAKING AT THE PENIS." CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614527 ↗
• MalfunctionApr 5, 2021Leak/Splash

  IT WAS REPORTED, "CATHETER WAS LEAKING AT THE MEATUS." CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614031 ↗
• InjuryJul 16, 2019Burst Container or Vessel

  A FEMALE PATIENT WAS HAD A FOLEY CATHETER IN PLACE FOR ONE DAY AND THE BALLOON BURST RESULTING IN THE CATHETER BEING REMOVED AND REPLACED WITH A NEW CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793209 ↗
• InjuryJul 16, 2019Leak/Splash

  A MALE PATIENT HAD A FOLEY CATHETER IN PLACE AND NOTICED THE CATHETER WAS LEAKING RESULTING IN THE CATHETER BEING REPLACED WITH A NEW CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8793134 ↗
• InjuryNov 9, 2018Deflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE INSERTED IN PATIENT, THE FOLEY CATHETER'S BALLOON DEFLATED RESULTING IN THE FOLEY CATHETER FALLING OUT FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055025 ↗
• MalfunctionAug 30, 2018Deflation Problem; Device Fell

  IT WAS REPORTED THAT WHILE INSERTED IN PATIENT, THE FOLEY CATHETER'S BALLOON DEFLATED RESULTING IN THE FOLEY CATHETER FALLING OUT FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7832214 ↗