Medline Industries, Inc. DYND150816TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10195327149871), received between Dec 22, 2023 and Sep 25, 2026 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896421 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888864 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859729 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that "there was a leakage in our foley bag."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820971 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789018 ↗
• MalfunctionSep 15, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779027 ↗
• MalfunctionSep 14, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

  It was reported that "Sample port detachment."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757908 ↗
• MalfunctionSep 12, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746297 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734745 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696785 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that "leaked drain bag."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695559 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  It was reported that "Leaking around foley catheter noted" and "A few hours later, it was noted to be leaking again."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691449 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  It was reported that there were "Leaking Foley Catheters".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669031 ↗
• MalfunctionSep 7, 2026Connection Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658482 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak; Leak/Splash

  ACCORDING TO THE CUSTOMER CONTACT, ON (B)(6) 2026, A FOLEY CATHETER WAS INSERTED, AND AFTER THE SYRINGE WAS DISCONNECTED, "FLUID WAS NOTICED AT THE URETHRAL OPENING COMING OUT AROUND THE CATHETER AND UPON RETRACTION OF THE CATHETER, IT COMPLETELY CAME OUT." THE FOLEY BALLOON WAS THEN TESTED AFTER REMOVAL AND WAS SHOWN TO BE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252973 ↗
• MalfunctionJan 30, 2026Fluid/Blood Leak; Device Dislodged or Dislocated; Material Split, Cut or Torn

  ACCORDING TO THE FACILITY ON 01/06/2026, AFTER A FOLEY CATHETER WAS INSERTED, THE BALLOON WAS INFLATED WITH STERILE WATER AND THE SYRINGE WAS DISCONNECTED. FLUID WAS NOTICED AT THE URETHRAL OPENING COMING OUT AROUND THE CATHETER, AND UPON RETRACTION OF THE CATHETER IT COMPLETELY CAME OUT. A SECOND ATTEMPT WAS MADE USING A NEW FOLEY KIT AND THE SAME ISSUE OCCURRED. A THIRD ATTEMPT WAS MADE USING A NEW FOLEY KIT AND NO PROBLEMS WERE REPORTED. THE ORIGINAL TWO FOLEY BALLOONS WERE TESTED AND WERE SHOWN TO BE LEAKING. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223320 ↗
• InjuryApr 4, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE CUSTOMER, THERE HAVE BEEN MULTIPLE INCIDENTS OF THE CATHETERS "NOT DRAINING THE BLADDER" AND THE CUSTOMER BELIEVES AN "OBSTRUCTION MAY HAVE OCCURRED AT THE TIP OF THE CATHETER".

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

  MAUDE report 21772876 ↗
• InjuryApr 10, 2024Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 AFTER AN "OPEN HEART" PROCEDURE, THE PATIENT'S FOLEY WAS "NOT DRAINING URINE DESPITE TROUBLESHOOTING".

  Patient problems: Urinary Retention

  MAUDE report 19081370 ↗
• MalfunctionMar 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER ON (B)(6) 2024, THE "PATIENT'S URINE OUTPUT HAD DRASTICALLY DECREASED OVERNIGHT AND EARLY IN THE MORNING AND THE PHYSICIAN WAS NOTIFIED".

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

  MAUDE report 18905945 ↗
• InjuryFeb 27, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE FACILITY ON (B)(6) 2024 "EMPTYING PORT WAS LEAKING URINE EVEN WHEN IN LOCKED POSITION".

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

  MAUDE report 18792903 ↗
• MalfunctionFeb 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON 1/17/24 THE TEMPERATURE PROBE DETACHED REQUIRING THE CATHETER TO BE REMOVED AND NEW CATHETER PLACED.

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

  MAUDE report 18764225 ↗
• InjuryFeb 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2024 THE TEMPERATURE PROBE DETACHED REQUIRING THE FACILITY TO REPLACE THE FOLEY CATHETER.

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

  MAUDE report 18740600 ↗
• MalfunctionDec 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  CATHETER REPLACED DUE TO STERILITY CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387339 ↗
• MalfunctionDec 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  CATHETER REPLACED DUE TO STERILITY CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387224 ↗