Bardex® I.C. Councill Model Foley Catheter 0196SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741017032), received between Jun 4, 2018 and Sep 21, 2023 — classified as 5 malfunctions.

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

• MalfunctionSep 21, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT MAIN OPERATING ROOM HAD TWO 20FR BALLOON COUNCIL MODEL CATHETER THAT THE BALLOON DID NOT EXPAND WHEN FLUID WAS INSERTED. PER FOLLOW UP VIA EMAIL ON (B)(6) 2023,CUSTOMER STATED THE SURGEON PERFORMED RIGHT URETEROSCOPY, HOLMIUM LASER LITHOTRIPSY, RIGHT STONE BASKET EXTRACTION, RIGHT URETERAL, STENT PLACEMENT AND COMPLEX FOLEY CATHETER PLACEMENT FOR A LARGE RIGHT URETERAL STONE. THE PRODUCT MALFUNCTION WAS DURING THE COMPLEX FOLEY CATHETER PLACEMENT . THE SURGEON REQUESTED A 20FR COUNCIL TIP CATHETER WHICH WAS SUPPLIED. UPON PLACING THE BALLOON FAILED AND REMOVING FROM PATIENT IT WAS DETERMINED THAT IT HAD A VERY PIN HOLE IN IT. A SECOND 20 FR COUNCIL TIP SUPPLIED AND WHEN PLACED THE BALLOON WOULD NOT INFLATED. THE CUSTOMER PERSONALLY LOOKED AT PACKAGING AND NOTICED BOTH WERE FROM SAME LOT SO RETRIEVED A THIRD 20FR COUNCIL TIP CATHETER FOR SURGEON FROM A DIFFERENT LOT WHICH WAS PLACED AND BALLOON INFLATED PROPERLY. ALL 20 FR COUNCIL TIP CATHETER IN THE LOT THAT HAD ISSUE PULLED FROM SHELF. PACKAGING FOR TWO OPENED WERE KEPT. THE FOLEYS THAT FAILED WERE DISCARDED BEFORE I COULD RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788212 ↗
• MalfunctionSep 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THEY HAD A DEFECTIVE ITEM FOR BARD 20 CH/FR (6.7MM) 5CC/ML RIBBED BALLOON COUNCIL MODEL RED LATEX RADIOPAQUE BARD HYDROGEL AND BACTI-GUARD SILVER ALLOY COATING AND THE ISSUE WAS REPORTED WAS THE WHOLE WHERE THE FOLEY CATHETER SYRINGE GAVE TO INFLATE THE BALLOON, IT WAS LEAKING. PER FOLLOW UP VIA PHONE ON 12SEP2023, N6HS0454 WAS REPORTED FOR DEFECTIVE PRODUCT. PER FOLLOW UP VIA PHONE ON 14SEP2023,THE CUSTOMER STATED THEY HAVE THE PRODUCT IN FRONT OF THEM AND THE LOT IS N6HS0454 PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 21SEP2023,THE WHOLE WHERE THE FOLEY CATHETER SYRINGE GAVE TO INFLATE THE BALLOON, IT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780087 ↗
• MalfunctionSep 19, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT MAIN OPERATING ROOM HAD TWO 20FR BALLOON COUNCIL MODEL CATHETER THAT THE BALLOON DID NOT EXPAND WHEN FLUID WAS INSERTED. AS PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, CUSTOMER STATED THE SURGEON PERFORMED RIGHT URETEROSCOPY, HOLMIUM LASER LITHOTRIPSY, RIGHT STONE BASKET EXTRACTION, RIGHT URETERAL, STENT PLACEMENT AND COMPLEX FOLEY CATHETER PLACEMENT FOR A LARGE RIGHT URETERAL STONE. THE PRODUCT MALFUNCTION WAS DURING THE COMPLEX FOLEY CATHETER PLACEMENT. THE SURGEON REQUESTED A 20FR COUNCIL TIP CATHETER WHICH WAS SUPPLIED. UPON PLACING THE BALLOON FAILED AND REMOVING FROM PATIENT IT WAS DETERMINED THAT IT HAD A VERY PIN HOLE IN IT .A SECOND 20 FR COUNCIL TIP SUPPLIED AND WHEN PLACED THE BALLOON WOULD NOT INFLATED .THE CUSTOMER PERSONALLY LOOKED AT PACKAGING AND NOTICED BOTH WERE FROM SAME LOT SO RETRIEVED A THIRD 20FR COUNCIL TIP CATHETER FOR SURGEON FROM A DIFFERENT LOT WHICH WAS PLACED AND BALLOON INFLATED PROPERLY. ALL 20 FR COUNCIL TIP CATHETER IN THE LOT THAT HAD ISSUE PULLED FROM SHELF. PACKAGING FOR TWO OPENED WERE KEPT. THE FOLEYS THAT FAILED WERE DISCARDED BEFORE IT COULD BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772675 ↗
• MalfunctionDec 30, 2020Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE AND CONTAMINATED. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 15DEC2020, THE CUSTOMER STATED THAT THE BALLOON EMPTIED APPROXIMATELY 2-3 CC FLUID. THE RESISTANCE WAS MET WHEN ATTEMPTING TO REMOVE THE TUBE AND THE PHYSICIAN STATED THAT THE RESISTANCE WAS AS NORMAL AS THE TUBE PASSED THROUGH THE FASCIA. THE PATIENT ATTEMPTED TO REMOVE AGAIN, RESISTANCE WAS MET, SLIGHTLY ADDED MORE PRESSURE AND THE TUBE WAS SUCCESSFULLY REMOVED AND THE BALLOON APPEARED TO REMAIN SEMI-INFLATED. THE PATIENT EXPERIENCED SELF LIMITED BLEEDING AT THE LEFT INCISION SITE AND THE BLEEDING WAS STOPPED AFTER APPLYING THE PRESSURE AT THE LEFT INCISION SITE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11096357 ↗
• MalfunctionJun 4, 2018Degraded; Material Integrity Problem; Degraded

  IT WAS REPORTED THAT THE CATHETERS WERE DRIED ROTTEN AND BALLOONS WERE NOT CENTERED, AS THEY INFLATED TOWARDS THE RIGHT SIDE.

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

  MAUDE report 7567415 ↗