Bardex® I.C. Foley Catheter 0167SI22Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741017315), received between Oct 3, 2019 and Dec 16, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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.

• MalfunctionDec 16, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THEY HAVE A DEFECTIVE FOLEY CATHETER, ONE OF THE 3 HOLES ON THE INSERTION TIP WAS RAISED, AND THE FLUID DID NOT FLOW OUT. THE WHOLE LOT WAS PULLED, SO THEY HAVE A TOTAL OF 8 TO BE RETURNED. (MATERIAL# 0167SI22, LOT# NGKR1988).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822279 ↗
• MalfunctionDec 16, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY HAVE A DEFECTIVE FOLEY CATHETER, ONE OF THE 3 HOLES ON THE INSERTION TIP WAS RAISED, AND THE FLUID DID NOT FLOW OUT. THE WHOLE LOT WAS PULLED, SO THEY HAVE A TOTAL OF 8 TO BE RETURNED. (MATERIAL# 0167SI22, LOT# NGKR1988).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821935 ↗
• MalfunctionSep 16, 2025Difficult to Remove; Defective Device; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT CUSTOMER HAVING ISSUES WITH 22FR 3-WAY 30CC FOLEY CATHETERS. THERE HAVE BEEN MULTIPLE INSTANCES WHERE THE UROLOGIST HAS HAD TROUBLE WITH ASPIRATING FROM THE FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062588 ↗
• MalfunctionMay 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT ASPIRATE OR IRRIGATE. IT DID ONE BUT NOT THE OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053988 ↗
• MalfunctionMar 10, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS BLOCKED AND WOULD NOT INFLATE OR FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558743 ↗
• MalfunctionFeb 3, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY BALLOON RUPTURED AT THE END OF A CASE. STAFF NOTICED THE FOLEY COMING OUT AND REALIZED THE BALLOON HAD RUPTURED. THE FOLEY WAS THEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293984 ↗
• 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 15982637 ↗
• MalfunctionJun 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT 3WAY FOLEY CATHETER WAS INSERTED AS PART OF THE PROCEDURE AND IT WAS NOT FLOWING. EVEN THE CLOT WAS FLUSHED AND ADJUSTED, IT CONTINUED TO NOT FLOW. ALSO STATED THAT THE BALLOON CUFF WOULD NOT DEFLATE AND CATHETER WAS REMOVED BY MANEUVERING AND REPLACED WITH SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093657 ↗
• MalfunctionJun 30, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 3-WAY FOLEY CATHETER WAS INSERTED AS PART OF THE PROCEDURE AND IT WAS NOT FLOWING. EVEN THE CLOT WAS FLUSHED AND ADJUSTED, IT CONTINUED TO NOT FLOW. ALSO STATED THAT THE BALLOON CUFF WOULD NOT DEFLATE, AND CATHETER WAS REMOVED AND REPLACED WITH SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093573 ↗
• MalfunctionDec 29, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT 2 OF THE FOLEY WERE UNABLE TO HOOK UP THE SYRINGE PROPERLY. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2020, STATED THAT 2 CATHETER WAS OPENED AND THE SYRINGE WAS NOT ATTACHED TO THE BALLOON PORT ON THE FIELD THEN USED A DIFFERENT SIZE 3-WAY CATHETER ON PATIENT AND KEPT ALL THE 6 FOR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11092803 ↗
• MalfunctionOct 3, 2019Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY WOULD NOT DEFLATE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9151555 ↗
• MalfunctionOct 3, 2019Fluid/Blood Leak; Leak/Splash; Gas/Air Leak; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON PORT WAS LEAKING THE FLUID PLACED IN IT CAUSING THE BALLOON TO DEFLATE AND DISLODGE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9151280 ↗