Medline URO170816TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10889942127955), received between Jan 31, 2022 and Sep 30, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  It was reported that "Detached Sample Port."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946990 ↗
• MalfunctionSep 8, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

  It was reported that "the sample port (Foley flushable port) came apart when RN went to flush the catheter."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674411 ↗
• MalfunctionMar 2, 2026Material Rupture

  ACCORDING TO THE FACILITY, "RN HEARD PATIENT SCREAM IN PAIN. RNS WENT TO BEDSIDE TO ASSESS PATIENT. PATIENT REPORTED FEELING SOMETHING "POP" INSIDE HER AND SAID IT WAS THE CATHETER. RN REMOVED CATHETER AND PLACED INTO TRASH.

  Patient problems: Pain

  MAUDE report 24491328 ↗
• MalfunctionSep 25, 2024Material Integrity Problem; Material Integrity Problem

  DETACHED TEMPERATURE PROBE.

  Patient problems: Insufficient Information

  MAUDE report 20302442 ↗
• InjurySep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY, " A TEMPERATURE PROBE DETACHED. A NEW CATHETER WAS PUT IN. THE PATIENT WAS NOT HARMED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301279 ↗
• MalfunctionJun 25, 2024Material Integrity Problem; Material Integrity Problem

  CATHETER WAS "CUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609816 ↗
• MalfunctionNov 27, 2023Material Puncture/Hole; Material Puncture/Hole

  "FOLEY PLACED BY SURGEON WAS OUT OF THE PATIENT AND ON THE FLOOR".

  Patient problems: Insufficient Information

  MAUDE report 18208870 ↗
• InjuryOct 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE FACILITY THE FOLEY CATHETER BALLOON RUPTURED REQUIRING THE CATHETER TO BE REPLACED.

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

  MAUDE report 17894643 ↗
• InjuryOct 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE FACILITY THE FOLEY CATHETER BALLOON RUPTURED REQUIRING THE CATHETER TO BE REPLACED.

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

  MAUDE report 17894491 ↗
• MalfunctionSep 5, 2023Break; Break

  DETACHED SAMPLE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684620 ↗
• InjuryOct 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY, 'A FOLEY CATHETER WAS PLACED INTO THE PATIENT'S BLADDER AND THE FOLEY ADVANCED ALL THE WAY TO THE HUB WITH GOOD URINE RETURN'. WHEN THE BALLOON WAS INFLATED WITH THE 'NORMAL AMOUNT OF STERILE WATER THE BALLOON BURST AND THE FOLEY CAME OUT'.

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

  MAUDE report 15596469 ↗
• InjuryOct 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, 'A FOLEY CATHETER WAS PLACED INTO THE PATIENT'S BLADDER AND THE FOLEY ADVANCED ALL THE WAY TO THE HUB WITH GOOD URINE RETURN'. WHEN THE BALLOON WAS INFLATED WITH THE 'NORMAL AMOUNT OF STERILE WATER THE BALLOON BURST AND THE FOLEY CAME OUT'.

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

  MAUDE report 15596221 ↗
• MalfunctionSep 6, 2022Material Rupture

  FOLEY CATHETER PLACED INTO PATIENT'S BLADDER UNDER NORMAL STERILE TECHNIQUE. THE FOLEY WAS PLACED NORMALLY INTO THE BLADDER WITH THE FOLEY ADVANCED ALL THE WAY TO THE HUB AND WITH GOOD URINE RETURN NOTED BEFORE BALLOON WAS INFLATED. WHEN BALLOON WAS INFLATED IT WAS FILLED WITH NORMAL AMOUNT OF STERILE WATER THAT COMES WITH THE KIT IN A PRE FILLED SYRINGE. WHEN INFLATED THE BALLOON BURST AND THE FOLEY CAME OUT. A SECOND FOLEY CATHETER WAS THEN PLACED SINCE THE FIRST FOLEY BALLOON BURST. WITH THE SECOND FOLEY THE EXACT SAME SCENARIO TOOK PLACE WITH THE SUBSEQUENT SAME RESULT. DR. THEN ATTEMPTED TO PLACE A 16FR NON TEMP SENSING FOLEY AND A 14FR COUDE WITH NO URINE RETURN AND NO FOLEY PLACED. A UROLOGY CONSULT WAS PLACED FOR POST PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15371085 ↗
• MalfunctionJan 31, 2022Leak/Splash

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BALLOON WAS LEAKING SO THE NURSE REMOVED THE FOLEY CATHETER AND REPLACED THE DEVICE WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404904 ↗