Medline UROT1058Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10193489604931), received between Aug 8, 2025 and Sep 16, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 2026Disconnection

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 50789026 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694626 ↗
• MalfunctionAug 12, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226665 ↗
• InjuryMar 25, 2026Connection Problem; Incomplete or Inadequate Connection

  THE ALL-IN-ONE URINARY CATHETER KIT WAS IN USE IN THE PATIENT. IN THIS KIT, THE URINARY CATHETER, TUBING, AND BAG ALL COME PRE-CONNECTED AND THE JUNCTION BETWEEN THE CATHETER AND TUBING IS SECURED WITH A TAPE. IN THIS CASE, THE TUBING BECAME DISCONNECTED FROM THE CATHETER WHILE THE TAPE REMAINED INTACT. PERHAPS THE ADHESIVE BROKE DOWN, THOUGH THAT IS UNCLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690393 ↗
• MalfunctionMar 2, 2026Break; Connection Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY, ON (B)(6), OBSERVED FOLEY IN PIECES ON THE BED, DRAIN INTACT IN PATIENT AND TUBING DISCONNECTED. REPLACED FOLEY.

  Patient problems: Insufficient Information

  MAUDE report 24485954 ↗
• InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY ON (B)(6) 2025 "THE TUBING SLID AWAY FROM THE YELLOW TAPE, THE TAPE REMAINED INTACT AND CONNECTED TO THE CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493732 ↗
• InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY ON (B)(6) 2025 "THE TUBING SLID AWAY FROM THE YELLOW TAPE, THE TAPE REMAINED INTACT AND CONNECTED TO THE CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490168 ↗
• InjuryNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY ON 9/10/2025, "THE TUBING SLID AWAY FROM THE YELLOW TAPE, THE TAPE REMAINED INTACT AND CONNECTED TO THE CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489016 ↗
• InjuryNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY ON (B)(6) 2025 "THE TUBING SLID AWAY FROM THE YELLOW TAPE, THE TAPE REMAINED INTACT AND CONNECTED TO THE CATHETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451999 ↗
• MalfunctionAug 8, 2025Connection Problem; Connection Problem

  FOLEY CATHETER DISCONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754646 ↗