Bardex® I.C. Complete Care® Foley Catheter Tray and Urine Meter 303318ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741024276), received between Jun 12, 2018 and Apr 25, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2019Deflation Problem

  IT WAS REPORTED THAT THE CATHETER WOULD NOT DEFLATE. THE PATIENT WAS TAKEN TO THE CLINIC FOR URETHROSCOPY TO DEFLATE THE FOLEY BALLOON WITH A BOTOX NEEDLE AND IT WAS REMOVED WITHOUT DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8550284 ↗
• MalfunctionJun 12, 2018Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THERE HAVE BEEN INSTANCES WHERE THE PATIENTS HAVE NOT HAD GOOD URINE OUTPUT. WHEN THE FOLEY WAS FLUSHED, REPLACED, OR THE BLADDER WAS SCANNED THERE WERE LARGE AMOUNTS OF URINE IN THE PATIENT'S BLADDER. ONCE THE CATHETER WAS REPOSITIONED AND MILKED, IT DRAINED 700CC OF URINE. THE COMPLAINANT STATED THE DRAINAGE ISSUES MAY NOT BE WITH THE CATHETER, HOWEVER POSSIBLY THE BLADDER.

  Patient problems: Urinary Retention

  MAUDE report 7594182 ↗