Bardex® Lubricath® Hematuria Coude Foley Catheter 2556H20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741025112), received between May 2, 2025 and Jun 24, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT CUSTOMER CALLED THAT THEIR BARD FOLEY CATHETER HAD COME OUT. SHOWED ONLY A TUBE AND NOTHING MORE. A MOMENT AGO, THERE WAS A POP AND FLUID WAS FLOWING. TAKES THE BARD CATHETER AND TAKES IT OUT TO THE SINK AND CHECKS WITH COLLEAGUES. THEY CONCLUDE THAT IT HAD BROKEN. IT LOOKS LIKE A CRACK GONE THROUGH IT AND THEY COULD CLEARLY SAW THAT EVERYTHING HAD COME OUT AND NOTHING WAS LEFT IN THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06JUN2025, STATED THAT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320986 ↗
• InjuryMay 2, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE ONLINE SURVEY THE NURSE STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS ((LEAKAGE), BLOCKAGE, (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)) ASSOCIATED WITH THE DEVICE 1852H18 BARD 2-WAY COUVELAIRE HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 18 FR AND IT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION ("HAD TO REMOVE THE CATHETER AND REINSERT ANOTHER CATHETER") AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT.

  Patient problems: Burning Sensation; Dysuria; Inflammation; Itching Sensation; Micturition Urgency; Skin Inflammation/ Irritation; Urinary Frequency / Polyuria

  MAUDE report 21950248 ↗
• InjuryMay 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE IN THE ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (EROSION / PRESSURE INJURY (CAMPI)) ASSOCIATED WITH THE DEVICE 1852H18 BARD 2-WAY COUVELAIRE HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 18 FR. AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT.

  Patient problems: Erosion; Pressure Sore/Ulcer

  MAUDE report 21950215 ↗