Medline Industries, Inc. URO175216Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10193489987393), received between Mar 8, 2023 and Sep 23, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  This VMSR report summarizes 2 malfunction events that occurred during Q2 2023 ((b)(6) 2023). The account reported that two URO175216 water-filled syringes experienced syringe tip breakage during use. The affected devices were associated with Lot Numbers 22KBC616 and 23BBD534. The customer reported that the syringe tips broke off during use, requiring use of an alternate syringe to complete the procedure. No patient harm was reported, and no medical intervention was required. Samples were reported as available and were returned for evaluation. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869565 ↗
• MalfunctionSep 12, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746728 ↗
• MalfunctionSep 9, 2026Failure to Deflate

  It was reported that when it was time to remove the foley, the balloon would not deflate. Once syringe was attached the fluid could not be pulled back.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691728 ↗
• MalfunctionSep 8, 2026Break

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671266 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT COLLECTION BAG SPONTANEOUSLY BURST OPEN AFTER SMALL AMOUNT OF URINE WAS COLLECTED.

  Patient problems: Insufficient Information

  MAUDE report 25308029 ↗
• MalfunctionMay 5, 2026Disconnection

  PER REPORT, "INSTALLATION PORT ON THE SIDE OF THE FOLEY DRAINAGE TUBE DISCONNECTS WHEN APPLYING EQUASHIELD. THIS RESULTS IN THE NEED TO DETACH THE DRAINAGE BAG FROM THE FOLEY AND REATTACH A NEW DRAINAGE BAG BEFORE PROCEEDING WITH INSTALLATION OF CHEMO INTO THE BLADDER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088337 ↗
• MalfunctionDec 30, 2025Fluid/Blood Leak; Obstruction of Flow; Failure to Deflate; Fluid/Blood Leak; Obstruction of Flow; Failure to Deflate

  ACCORDING TO THE FACILITY, PATIENT HAD A FOLEY CATHETER INSERTED ON (B)(6) 2025, AND ON (B)(6) 2025, WENT TO THE ER BECAUSE THE CATHETER WAS NOT "DRAINING MUCH" AND WAS "LEAKING AROUND THE TIP." RN AND DOCTOR ATTEMPTED TO DRAIN THE BALLOON, BUT IT WOULD NOT DRAIN COMPLETELY.

  Patient problems: Discomfort; Genital Bleeding; Pain

  MAUDE report 23927868 ↗
• InjuryJun 30, 2025Material Rupture; Material Rupture

  RETAINED FOLEY BALLOON FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22365943 ↗
• MalfunctionJun 3, 2024Inflation Problem; Inflation Problem

  FOLEY CATHETER BALLOON WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448459 ↗
• InjuryMar 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THERE WAS AN ISSUE WITH A FOLEY CATHETER BALLOON REQUIRING AN ADDITIONAL CATHETER TO BE PLACED.

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

  MAUDE report 16502040 ↗