Bardia® Urethral Catheter 802410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741018336), received between Jun 19, 2019 and May 19, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE BARDIA URETHRAL CATHETER WAS NOT WELL SEALED IN ITS PRIMARY PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434852 ↗
• InjuryApr 19, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION AND ALTHOUGH THERE WAS NO ALLEGATION AGAINST THE PRODUCT. HISTORICALLY, THE PATIENT WAS PROVIDED WITH THE TOUCHLESS PLUS CATHETER. PER SAMPLE RECEIVED ON 23MAR2020, IT WAS NOTED THAT A BARDIA URETHRAL RED RUBBER CATHETER WAS RECEIVED FOR EVALUATION. IT WAS UNKNOWN WHETHER MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11689433 ↗
• InjurySep 14, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS NO LONGER USING THE CATHETERS. THE PATIENT GOT AN INFECTION DUE TO USING THESE CATHETERS EACH TIME. ALSO STATED THAT THE PATIENT WAS NOT USING ANY SUPPLY BECAUSE OF IT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10528292 ↗
• MalfunctionJun 19, 2019Misassembled; Misassembled; Component Missing

  IT WAS REPORTED THAT THE CATHETERS DID NOT HAVE ANY EYELETS MAKING IT UNUSABLE.

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

  MAUDE report 8713776 ↗