Medline Industries, Inc. URO175516Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10193489988949), received between Aug 2, 2023 and Sep 16, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792775 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  It was reported that "the whole port popped off, resulting in formula and urine pouring out".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610304 ↗
• MalfunctionApr 8, 2026Material Split, Cut or Torn; Unintended Deflation

  ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, "FOLEY CATHETER WAS INSERTED INTO PATIENT. ONCE URINE RETURN WAS SEEN, CATHETER WAS ADVANCED AND BALLOON WAS INFLATED. RESISTANCE WAS NOT FELT. WHEN CLEANING UP THE USED FOLEY KIT AND MOVING THE FOLEY BAG AROUND, THE FOLEY CATHETER SLID OUT OF THE PATIENT WITH THE BALLOON DEFLATED".

  Patient problems: Hematuria

  MAUDE report 24820735 ↗
• MalfunctionJul 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FOLEY CATHETER "EXPELLED BACK OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387132 ↗
• InjuryJun 21, 2024Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE CUSTOMER, ON 05/17/2024 THE "FOLEY BALLOON RUPTURED IN PATIENT" REQUIRING THE CATHETER TO BE "REMOVED AND REPLACED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584808 ↗
• InjuryAug 2, 2023Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THE FOLEY WAS "CRUNCHY" AND REQUIRED A NEW CATHETER TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445497 ↗
• InjuryAug 2, 2023Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THE FOLEY WAS "CRUNCHY" AND REQUIRED A NEW CATHETER TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444388 ↗