Bardex® I.C. Foley Catheter 0167SI24Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741017322), received between Dec 14, 2022 and Jun 12, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLEY CATHETER STOPPED DRAINING. THE NURSE WAS GOING TO REPLACE, SO THEY ASPIRATED ON THE BALLOON PORT AND DID NOT GETTING ANY VOLUME. THE BALLOON PORT WAS NOTED TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107217 ↗
• MalfunctionJun 12, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CUSTOMER WERE UNABLE TO DEFLATE THE FOLEY BALLOON TO REMOVE DUE TO INABILITY IRRIGATE/DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107213 ↗
• MalfunctionJun 12, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WERE UNABLE TO DEFLATE THE FOLEY BALLOON TO REMOVE DUE TO INABILITY IRRIGATE/DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106149 ↗
• MalfunctionJun 12, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER STOPPED DRAINING. THE NURSE WAS GOING TO REPLACE, SO THEY ASPIRATED ON THE BALLOON PORT AND DID NOT GETTING ANY VOLUME. THE BALLOON PORT WAS NOTED TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106148 ↗
• MalfunctionJun 9, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD GOTTEN COMPLAINTS FROM A COUPLE OF THE UROLOGY DOCTORS ABOUT FOLEY CATHETER. CUSTOMER HAD FOLEY CATHETER WITH ISSUES OF THEIR BALLOONS LEAKING. ONE SURGEON FILLED THEIR BALLOON WITH 30 CC¿S, PATIENT WAS TRANSFERRED TO THE FLOOR AND IT WAS FOUND THAT THE CATHETER HAD MIGRATED TO THE PATIENT¿S PROSTATE . ANOTHER LAST NIGHT FILLED THEIR BALLOON IN THE OPERATION ROOM AND BY THE TIME THEY GOT TO PACU, IT CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097456 ↗
• MalfunctionJun 1, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT CUSTOMER HAD GOTTEN COMPLAINTS FROM A COUPLE OF THE UROLOGY DOCTORS ABOUT FOLEY CATHETER. CUSTOMER HAD FOLEY CATHETER WITH ISSUES OF THEIR BALLOONS LEAKING. ONE SURGEON FILLED THEIR BALLOON WITH 30 CC¿S, PATIENT WAS TRANSFERRED TO THE FLOOR, AND THIS AM, IT WAS FOUND THAT THE CATHETER HAD MIGRATED TO THE PATIENT¿S PROSTATE. ANOTHER LAST NIGHT FILLED THEIR BALLOON IN THE OPERATION ROOM AND BY THE TIME THEY GOT TO PACU, IT CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037290 ↗
• MalfunctionJun 1, 2023Migration; Migration

  IT WAS REPORTED THAT CUSTOMER HAD GOTTEN COMPLAINTS FROM A COUPLE OF THE UROLOGY DOCTORS ABOUT FOLEY CATHETER. CUSTOMER HAD FOLEY CATHETER WITH ISSUES OF THEIR BALLOONS LEAKING. ONE SURGEON FILLED THEIR BALLOON WITH 30 CC¿S, PATIENT WAS TRANSFERRED TO THE FLOOR, AND THIS AM, IT WAS FOUND THAT THE CATHETER HAD MIGRATED TO THE PATIENT¿S PROSTATE. ANOTHER LAST NIGHT FILLED THEIR BALLOON IN THE OPERATION ROOM AND BY THE TIME THEY GOT TO PACU, IT CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037289 ↗
• MalfunctionFeb 9, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AND WAS BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334881 ↗
• MalfunctionJan 31, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE IRRIGATION CHANNEL OF THE FOLEY CATHETER PLACED WAS BLOCKED, AND THE CUSTOMER STATED THAT A DEFECTIVE ITEM HAD BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271691 ↗
• MalfunctionJan 30, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL ISSUES WITH 22FR AND 24FR 30CC 3-WAY FOLEY CATHETERS HAVING THE IRRIGATION CHANNEL OBSTRUCTED. PREVENTING TIMELY PLACEMENT OF SURGEON¿S CONTINUOUS BLADDER IRRIGATION. THE LATEST INCIDENT WAS WITH THE 24FR 30CC 3-WAY FOLEY CATHETERS. STATED THAT THE CUSTOMER PULLED ALL FOLEYS HAVING THE SAME LOT AND REFERENCE AND TESTED ONE FROM THEIR COLLECTION AND FOUND NO OBSTRUCTION TO BOTH IRRIGATION AND DRAINAGE CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16267554 ↗
• MalfunctionDec 19, 2022Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE SURVEY RESPONDENT WAS ASKED IF THEY WERE ABLE TO SUCCESSFULLY IRRIGATE WHILE USING THE PRODUCT AS PART OF A PATIENT CHART AUDIT IN RELATION TO THE BARDEX I.C. 3-WAY IRRIGATION FOLEY CATHETER. THE RESPONDENT INDICATED NO AND WHEN ASKED TO ELABORATE WHY THEY WERE NOT ABLE TO SUCCESSFULLY PLACE THE FOLEY CATHETER IN A PATIENT THEY INDICATED ¿NOT USEFUL¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005379 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT WAS ASKED WHETHER THEY BELIEVE THE BENEFITS OF USING THE PRODUCT OUTWEIGH THE POTENTIAL RISKS IN RELATION TO THE BARDEX I.C. 3-WAY IRRIGATION FOLEY CATHETER AS PART OF A CUSTOMER SURVEY. THE RESPONDENT INDICATED THAT NO, THE BENEFITS OF USING THIS PRODUCT DO NOT OUTWEIGH THE POTENTIAL RISKS. WHEN ASKED TO ELABORATE, THE RESPONDENT STATED URETHRAL INJURY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETHRAL INJURY (0167SI16, 0167SI18, 0167SI20, 0167SI22, 0167SI24, 0167SI26).

  Patient problems: Tissue Breakdown

  MAUDE report 15980007 ↗