Bardex Lubricath Foley Catheter Councill ModelRecalls & reported problems across all models

We found 4 models of Bardex Lubricath Foley Catheter Councill Model by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2017 and Sep 10, 2026 — classified as 4 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bardex Lubricath Foley Catheter Councill Model problems

Bardex Lubricath Foley Catheter Councill Model models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bardex® Lubricath® Foley Catheter Councill Model 0196L16

  CATHETER, COUDE
  23 reports
• Bardex® Lubricath® Foley Catheter Councill Model 0196L18

  CATHETER, COUDE
  20 reports
• Bardex® Lubricath® Foley Catheter Councill Model 0196L20

  CATHETER, COUDE
  9 reports
• Bardex® Lubricath® Foley Catheter Councill Model 0196L22

  CATHETER, COUDE
  5 reports

Recent Bardex Lubricath Foley Catheter Councill Model adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722283 ↗
• MalfunctionSep 4, 2026Material Puncture/Hole

  It was reported that Customer had experienced with at least three of our Bard Council Tip catheters. Instead of the balloon inflating at the tip of the catheter within the patient's bladder, it inflated at the fork where the syringe connection and foley bag attachment sites were located. For today¿s issue, the REF# is (b)(4) and the LOT# is NGLR3780. Customer also had issues where there was a leak at the Y junction and the fluid in the balloon port leaked out. They had two patient's council catheters fell out after surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620017 ↗
• MalfunctionSep 4, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612422 ↗
• MalfunctionJul 31, 2026Inaccurate Flow Rate; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105790 ↗
• MalfunctionJul 31, 2026Nonstandard Device; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100483 ↗
• InjuryMar 4, 2026Material Puncture/Hole; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE WRITER WENT IN TO ASSESS THE PATIENT, NO DRAINAGE WAS NOTED IN THE FOLEY BAG. AT THE START OF THE SHIFT, A SMALL AMOUNT OF DRAINAGE HAD BEEN OBSERVED IN THE TUBING. THE WRITER ASKED THE PATIENT IF THE BAG HAD BEEN EMPTIED, AND THE PATIENT STATED THAT IT HAD NOT. THE FOLEY TUBING HAD BEEN ROUTED THROUGH THE PATIENT¿S PANTS, MAKING IT IMPOSSIBLE TO SEE WHETHER IT WAS SECURED IN THE LEG STRAP. A BLADDER SCAN SHOWED 800 ML. THE PATIENT REPORTED BEING COMFORTABLE AND DID NOT FEEL AN URGE TO VOID. WHEN THE PATIENT REMOVED THEIR PANTS, THE FOLEY CATHETER WAS FOUND TO BE OUT OF PLACE WITH THE BALLOON DEFLATED. NO TRAUMA WAS NOTED TO THE PENIS, AND THE PATIENT STATED THEY DID NOT FEEL ANY PAIN OR A ¿TUG¿ AND WERE UNSURE HOW IT HAPPENED. THE FOLEY CATHETER WAS PLACED IN A SPECIMEN BAG AND PROVIDED TO THE CNE.

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

  MAUDE report 24506147 ↗
• MalfunctionFeb 3, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE LATEX FOLEYS WERE NOT STAYING INFLATED AND WERE FALLING OUT OF PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250907 ↗
• MalfunctionJan 30, 2026Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO DEFLATE FOLEY CATHETER BALLOON TO REMOVE FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223863 ↗
• MalfunctionDec 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER WOULD NOT DEFLATE FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871904 ↗
• MalfunctionSep 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED INTO THE PATIENT, THE BALLOON WAS INFLATED, HOWEVER THE CATHETER DID NOT STAY IN THE PATIENT, IT FELL OUT. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 23SEP2025, CUSTOMER WAS STILL WAITING FOR THE BOX. THEY HAVE ONE DRAIN THAT WAS USED ON THE PATIENT, AND THE REST IN ITS BOX WITH THE SAME LOT NUMBER. CUSTOMER CANNOT GIVE OUT ANY MEDICAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030868 ↗
• MalfunctionJul 7, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER USED THIS PARTICULAR CATHETER ON THREE DIFFERENT PATIENTS, AND EACH ONE HAD A BALLOON FAILURE. HE INSERTED THE CATHETER INTO THE PATIENT, BLEW UP THE BALLOON, AND THE BALLON FAILED, HAVING THE CATHETER FALL OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412739 ↗
• MalfunctionJul 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE OF THE SURGEONS WENT TO BLOW THE BALLOON AND IT MALFUNCTIONED AND FELL OFF THE PT. THIS ISSUE OCCURRED ON A TOTAL OF 3 INSTANCES ON DIFFERENT PATIENT. DOE FOR ONE OF THE EVENTS (B)(6), OTHER DATES NOT AVAILABLE. 1 SAMPLE AVAILABLE FOR RETURN REF: (B)(4), LOT NGHS088.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383972 ↗
• MalfunctionJun 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE OF THE SURGEONS WENT TO BLOW THE BALLOON AND IT MALFUNCTIONED AND FELL OFF THE PT. THIS ISSUE OCCURRED ON A TOTAL OF 3 INSTANCES ON DIFFERENT PATIENT. DOE FOR ONE OF THE EVENTS (B)(6) , OTHER DATES NOT AVAILABLE. 1 SAMPLE AVAILABLE FOR RETURN REF: (B)(4) , LOT NGHS088.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357843 ↗
• MalfunctionJun 24, 2025Material Rupture; Material Rupture

  CUSTOMER SAID THAT THE BALLOON POPPED. PATIENT EMAIL ADDRESS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324974 ↗
• MalfunctionApr 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE PATIENT THAT THE FOLEY CATHETERS ARE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21839163 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports