Bard® Urologist's Tray 123400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741000294), received between Feb 5, 2019 and Apr 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2025Class IIOpen, Classified

   Cather packaging may contain the incorrect French size.

   Z-2076-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS HOLE IN THE BULB THAT INFLATES THE FILIFORM CATHETER.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 21751305 ↗
• MalfunctionSep 3, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT 1 BARD UROLOGIST TRAY WAS ALREADY OPEN UPON RECEIVING THE PRODUCT. CUSTOMER WOULD LIKE A REPLACEMENT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126295 ↗
• MalfunctionOct 5, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE WIRE IN THIS UROLOGIST TRAY SEEMS TO BE DIFFERENT. CUSTOMER USED IT FOR SIX OR SEVEN YEARS NOW AND NEVER HAD A PROBLEM UNTIL RECENTLY. THE WIRE HAS BEEN BENDED IN THE LAST THREE CASES THAT THEY HAVE USED THE BARD UROLOGIST TRAY. CUSTOMER KEPT HAD TO OPEN DIFFERENT WIRES. (BATCH#NGGY5965) AND BATCH# UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878456 ↗
• MalfunctionOct 5, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE WIRE IN THIS UROLOGIST TRAY SEEMS TO BE DIFFERENT. CUSTOMER USED IT FOR SIX OR SEVEN YEARS NOW AND NEVER HAD A PROBLEM UNTIL RECENTLY. THE WIRE HAS BEEN BENDED IN THE LAST THREE CASES THAT THEY HAVE USED THE BARD UROLOGIST TRAY. CUSTOMER KEPT HAD TO OPEN DIFFERENT WIRES. (BATCH#NGGY5965).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876874 ↗
• MalfunctionJul 13, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING TRAY, IT WAS MISSING BOTH CATHETERS FROM MIDDLE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319160 ↗
• MalfunctionApr 21, 2022Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE BARD UROLOGIST'S TRAY WAS WET WHEN IT ARRIVED AND LOOKED LIKE THE PRODUCT HAD SOME WATER DAMAGE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167094 ↗
• MalfunctionJan 30, 2020Break; Melted; Break

  IT WAS REPORTED THAT UPON OPENING PACKAGING BUT BEFORE USE, THE PRODUCT WAS MELTED.

  Patient problems: No Patient Involvement

  MAUDE report 9647825 ↗
• MalfunctionFeb 5, 2019Misassembled; Tear, Rip or Hole in Device Packaging; Misassembled

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE WIRE WAS POKING OUT OF CATHETER.

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

  MAUDE report 8307078 ↗