Bardex® I.C. Complete Care® Urine Meter Foley Tray 903016ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741019876), received between May 3, 2017 and Jun 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gel Leak” (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 18, 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.

• MalfunctionJun 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PRE-TESTING, THE TIP OF THE SYRINGE BROKE OFF WHEN THE SYRINGE WAS CONNECTED TO THE INFLATION VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177594 ↗
• MalfunctionApr 17, 2018Gel Leak; Gel Leak; Leak/Splash

  IT WAS REPORTED THAT THE LUBRICANT LEAKED INSIDE OF THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7436997 ↗
• MalfunctionMay 3, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT PRODUCT 903016A WAS ORDERED; HOWEVER, WHEN THE SHIPMENT WAS RECEIVED, THE BOX CONTAINED PRODUCT 902916 INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540501 ↗