Medline URO2S0615TKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277875050), received between Mar 9, 2026 and Sep 9, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Free or Unrestricted Flow” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Gas/Air Leak

  It was reported that "We just had another episode of air in the bladder on one of our babies on ECMO with a temp sensing foley. The baby has a 6Fr catheter in place. It was placed 8/4 but the air didn't accumulate until 8/13. The baby was leaking urine around the catheter last night, so they removed the fluid from the balloon and reinflated without incident. The air was noted on Xray the following morning."

  Patient problems: Insufficient Information

  MAUDE report 50681956 ↗
• InjuryMar 10, 2026Free or Unrestricted Flow

  ACCORDING TO THE FACILITY ON OR ABOUT (B)(6) 26 TO (B)(6) 26, TWO SEPARATE EVENTS INVOLVING DIFFERENT NICU PATIENTS ON ECMO. IN BOTH CASES, 6 F TEMPERATURE SENSING CATHETERS WERE USED, AND UPON REMOVAL OF PARALYTICS, THE PATIENTS' BLADDERS WERE NOTED TO FILL WITH AIR. ACCORDING TO THE FACILITY ON OR ABOUT (B)(6) 26 TO (B)(6) 26, TWO SEPARATE EVENTS INVOLVING DIFFERENT NICU PATIENTS ON ECMO. IN BOTH CASES, 6 F TEMPERATURE SENSING CATHETERS WERE USED, AND UPON REMOVAL OF PARALYTICS, THE PATIENTS' BLADDERS WERE NOTED TO FILL WITH AIR.

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

  MAUDE report 24558734 ↗
• MalfunctionMar 9, 2026Insufficient Device Problem Information

  "ACCORDING TO THE FACILITY, A 6 FR TEMPERATURE SENSING CATHETER WAS USED ON A NICU PATIENT ON ECMO, AND UPON REMOVAL OF PARALYTICS, THE PATIENT'S BLADDER WAS NOTED TO FILL WITH AIR."

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

  MAUDE report 24552260 ↗