Bardex® I.C. Foley Catheter 1857SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741017346), received between Jan 6, 2021 and May 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 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 30, 2025Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A NURSE STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY IRRIGATE THE PATIENT WHILE USING 1857H18 BARD 3-WAY DUFOUR HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 18 FR. BECAUSE OF "PERSONEL RELATED". PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 05JUN2025, STATED THAT NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114813 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING. THE PATIENT NEEDED TWO-WAY CATHETER, THEY DID NOT NEEDED THREE WAY. SO THEY NEED TO SPOKE WITH DOCTOR ABOUT THIS. THE PATIENT HAD BEEN USING THIS PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779107 ↗
• MalfunctionJun 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT NEEDED A 2-WAY FOLEY CATHETER BECAUSE THE 3-WAY FOLEY CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041041 ↗
• InjuryJan 6, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS CONSTANTLY GETTING BLADDER INFECTIONS FROM THE FOLEY CATHETERS AND WANTED TO SWITCH FOR A SILVER COATED FOLEY. IT WAS NOTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION REGARDLESS OF THE CATHETER USED THEY WANTED TO TRY THE SILVER COATED TO REDUCE THE RISK. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE BLADDER INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11125672 ↗