Bardex® I.C. Foley Catheter 1857SI22Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741017360), received between Apr 11, 2025 and May 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2026Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD URETERAL STRICTURE AND UNDERWENT SURGICAL TREATMENT. DURING THE SURGERY, FOLEY CATHETER BALLOON DILATION OF THE URETERAL STRICTURE WAS PERFORMED. CURRENTLY, THE GUIDEWIRE CANNOT PASS THROUGH THE BALLOON CHANNEL. IT WAS ONLY AFTER SWITCHING TO A SUPER-SLIPPERY GUIDEWIRE FROM THE VASCULAR DEPARTMENT THAT IT COULD BE USED, WHICH AFFECTED THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133587 ↗
• MalfunctionDec 11, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER HAS SEEN A FEW 22FR OPEN TIP CATHETERS # 1857SI22 BEING OCCLUDED, MEANING THE OPENING OF THE CATHETER WAS BLOCKED AND BECAUSE OF IT, THEY HAD TO REPLACE THE CATHETER ON A FEW PATIENTS AFTER BEING INSERTED IN THE OPERATING ROOM. CUSTOMER HAS SAMPLE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777928 ↗
• MalfunctionNov 10, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER HAS SEEN A FEW 22FR OPEN TIP CATHETERS 1857SI22 BEING OCCLUDED, MEANING THE OPENING OF THE CATHETER WAS BLOCKED AND BECAUSE OF IT, THEY HAD TO REPLACE THE CATHETER ON A FEW PATIENTS AFTER BEING INSERTED IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513230 ↗
• MalfunctionOct 21, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THEY PLACED A THREE-WAY CATHETER AT THE END OF A TURP. THEY USED THE BARDEX IC CATHETER LOT NUMBER NGKT1854. NUMBER OF US ARE STRUGGLING WITH THE FLOW ON THESE. AS IS DOCUMENTED BY THE NURSE THEY HAD TO COME TO THE BEDSIDE AND CHANGE OUT THIS CATHETER. IT APPEARS THAT THERE WAS A FLOW ISSUE RELATED TO THIS CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350917 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WRITER WAS INFORMED BY PRIMARY THAT PATIENT'S FOLEY CATHETER WAS EXTREMELY LONG PRIOR TO TRANSFERRING PATIENT TO BED, CBI RUNNING MODERATE#1, RIGHT GROIN BULGE SEEN, PALPATED HARD COMPARED TO LEFT SIDE, NO HISTORY HERNIA. PATIENT IN 8/10 PAIN. WRITER CALLED RECOVERY NURSE, WAS INFORMED PATIENT WAS NOT LIKE THIS PRIOR TO TRANSFER, NO BULGE SEEN. FOLEY HAD FAULTY BALLOON, WAS ABLE TO REMOVE CATHETER WITH EASE. MINIMAL HARM TO THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 21825555 ↗