Bardex® Urethral Catheter Whistle Tip 055016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741033254), received between Jul 31, 2023 and Jul 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THEY WERE LONG TIMER USERS OF THE WHISTLE TIP AND UPON STARTING TO USE THE CATHETER IT DID NOT FIT AS A 16FR SHOULD. AS PER THE FOLLOW UP RECEIVED ON 06JUL2023, THE SALES REPRESENTATIVE RESPONDED THAT THE ONE THAT WAS USED AND CLEARLY NOTICED IN USE WAS NOT A 16FR. IT WAS THROWN AWAY. AND THE CUSTOMER WAS GIVEN FOUR UNOPENED CATHETERS THAT THEY DESCRIBED AS 16FR, BUT WHEN COMPARED WITH A DIFFERENT LOT OF 16FR, THEY WERE CLEARLY SMALLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423482 ↗