Bardex® Foley Catheter Silicone Coated 0167V20SRecalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 00801741019227), received between Jun 16, 2020 and Sep 28, 2026 — classified as 9 injuries, 166 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (83 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 25 most recent of 175 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  It was reported that while making rounds in the ward, they noticed that the patient¿s pelvic drainage output had decreased compared to previous readings. Upon examining the drainage tubing balloon, they found that no sterile water was drawn back when they aspirated the balloon. When they gently pulled on the pelvic drainage tubing, it came out on its own, and the balloon was found to be ruptured vertically. they reported this to the on-call physician, who assessed the patient¿s condition and decided not to reinsert the tubing, instructing instead that the patient be kept under observation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924427 ↗
• MalfunctionSep 25, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904193 ↗
• MalfunctionSep 25, 2026Material Rupture

  It was reported that following a transurethral holmium laser enucleation of the prostate (HoLEP) on (b)(6), a three way urinary foley catheter was indwelling. On (b)(6), during a patient repositioning maneuver, a "pop" sound was heard from the lower abdomen, and the catheter was immediately expelled along with the urine; inspection revealed a ruptured balloon, and a subsequent check confirmed the balloon's integrity with no residual fragments.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899377 ↗
• MalfunctionSep 24, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889828 ↗
• MalfunctionSep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829607 ↗
• MalfunctionSep 18, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828918 ↗
• MalfunctionSep 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809597 ↗
• MalfunctionSep 17, 2026Material Puncture/Hole

  It was reported that Patient (b)(6)2026 (b)(6), The patient underwent a ¿laparoscopic radical prostatectomy¿ under general anesthesia. A urinary catheter was left in place postoperatively; the urine was pale yellow. On (b)(6)2026, (b)(6), The nurse disinfected the urinary tubing and discovered that it had slipped out. Upon questioning the patient, he reported having coughed several tens of minutes earlier and experiencing mild pain at the urethral opening but had not noticed that the tubing had slipped out.

  Patient problems: Pain

  MAUDE report 50804202 ↗
• MalfunctionSep 15, 2026Material Rupture

  Patient problems: Abdominal Distention; Abdominal Pain; Pain

  MAUDE report 50781533 ↗
• MalfunctionSep 14, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765263 ↗
• MalfunctionSep 9, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702142 ↗
• MalfunctionSep 9, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696504 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452736 ↗
• MalfunctionAug 4, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130668 ↗
• MalfunctionJul 31, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105795 ↗
• MalfunctionJul 30, 2026Material Rupture

  It was reported that the department reported the balloon ruptured during use. Product model 123420C. The department has been using this product for many years and reports no operational issues. This is the fourth instance of rupture or detachment involving this same product at the same hospital within a short period of time. Please investigate the root cause to prevent damage to the products reputation within the department.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084498 ↗
• MalfunctionJul 27, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022126 ↗
• MalfunctionJul 21, 2026Material Rupture

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894888 ↗
• MalfunctionJul 20, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882502 ↗
• MalfunctionJun 25, 2026Inflation Problem

  IT WAS REPORTED THAT ON JUNE 9, THE PATIENT UNDERWENT TRANSURETHRAL CYSTOSCOPIC LASER LITHOTRIPSY AND PARTIAL PLASMA RESECTION OF THE PROSTATE UNDER GENERAL ANESTHESIA FOR BLADDER STONES AND PROSTATIC HYPERPLASIA. FOLLOWING STANDARD SURGICAL PROTOCOL, A NO. 20 BARD INDWELLING URINARY FOLEY CATHETER WAS INSERTED. THE PROCEDURE WAS PERFORMED CORRECTLY: PATIENT POSITIONING AND INSERTION TECHNIQUE WERE ACCURATE, THE INSERTION DEPTH MET STANDARDS, AND THE BALLOON WAS PROPERLY INFLATED FOR FIXATION. IMMEDIATELY AFTER INSERTION, THE SURGEON ATTEMPTED TO INJECT FLUID INTO THE CATHETER'S INFLATION PORT BUT ENCOUNTERED RESISTANCE. DESPITE REPEATED ADJUSTMENTS TO THE CATHETER POSITION, SQUEEZING OF THE DRAINAGE TUBE, AND EFFORTS TO RULE OUT FACTORS SUCH AS TUBE KINKING, COMPRESSION, TWISTING, BLOOD CLOT OBSTRUCTION, OR URETHRAL SPASMS, THE ISSUE PERSISTED, SUGGESTING AN INTERNAL OBSTRUCTION OR NARROWING OF THE CATHETER LUMEN. THE CATHETER WAS PROMPTLY REPLACED; THE NEW CATHETER PROVIDED UNOBSTRUCTED DRAINAGE, AND THE SURGERY PROCEEDED AS PLANNED. THIS INCIDENT PROLONGED THE OPERATIVE TIME AND INCREASED THE WORKLOAD FOR THE MEDICAL TEAM; FURTHERMORE, THE REPEATED CATHETERIZATION CAUSED INJURY

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25623682 ↗
• MalfunctionJun 17, 2026Partial Blockage

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT WAS IN THE OPERATING ROOM. DURING THE SURGERY, TRIED TO FLUSH THE BLADDER, BUT THE ISOTONIC SOLUTION COULDN'T GET INTO THE FOLEY CATHETER. EVEN AFTER SWITCHING THE IRRIGATION DEVICE, NOTHING CHANGED. WE SUSPECTED AN ISSUE WITH THE CATHETER, SO WE REMOVED IT AND FOUND THAT ONE LUMEN THROUGH WHICH THE IRRIGATION FLUID SHOULD GO WAS BLOCKED, PREVENTING THE FLUID FROM ENTERING THE CATHETER. WE DISCARDED IT, REPLACED IT WITH A NEW CATHETER, CONNECTED THE IRRIGATION FLUID, AND WERE ABLE TO SUCCESSFULLY FLUSH THE PATIENT'S BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538319 ↗
• InjuryJun 17, 2026Partial Blockage

  IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT HAD A THREE-LUMEN FOLEY CATHETER CONTINUOUSLY IRRIGATED WITH SALINE INTO THE BLADDER. AT 10:00 PM, THE PATIENT COMPLAINED OF A FEELING OF URINARY URGENCY; THE ABDOMEN FELT BLOATED ON TOUCH, AND THE BLADDER SALINE IRRIGATION WAS NOT FLOWING WELL. NEGATIVE PRESSURE ASPIRATION WAS PERFORMED WITH A 50ML SYRINGE, BUT NO DRAINAGE FLUID WAS OBTAINED. AT 11:20 PM, BEDSIDE ULTRASOUND: THE ON-DUTY DOCTOR ADJUSTED THE CATHETER AND SCANNED AGAIN AFTER INJECTING SALINE; A CATHETER-LIKE ECHO WAS SEEN IN THE BLADDER, BUT NO BALLOON-LIKE ECHO WAS OBSERVED. THE THREE-LUMEN CATHETER WAS REMOVED, AND THE CATHETER BALLOON WAS FOUND TO BE BROKEN.

  Patient problems: Abdominal Distention; Micturition Urgency

  MAUDE report 25538204 ↗
• MalfunctionJun 17, 2026Material Rupture

  IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT HAD A THREE-LUMEN FOLEY CATHETER CONTINUOUSLY IRRIGATED WITH SALINE INTO THE BLADDER. AT 10:00 PM, THE PATIENT COMPLAINED OF A FEELING OF URINARY URGENCY; THE ABDOMEN FELT BLOATED ON TOUCH, AND THE BLADDER SALINE IRRIGATION WAS NOT FLOWING WELL. NEGATIVE PRESSURE ASPIRATION WAS PERFORMED WITH A 50ML SYRINGE, BUT NO DRAINAGE FLUID WAS OBTAINED. AT 11:20 PM, BEDSIDE ULTRASOUND: THE ON-DUTY DOCTOR ADJUSTED THE CATHETER AND SCANNED AGAIN AFTER INJECTING SALINE; A CATHETER-LIKE ECHO WAS SEEN IN THE BLADDER, BUT NO BALLOON-LIKE ECHO WAS OBSERVED. THE THREE-LUMEN CATHETER WAS REMOVED, AND THE CATHETER BALLOON WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538053 ↗
• MalfunctionJun 16, 2026Material Rupture

  IT WAS REPORTED THAT PATIENT¿S POSTOPERATIVE CONDITION REQUIRED AN INDWELLING URINARY CATHETER FOR BLADDER IRRIGATION. PATIENT NOTICED INVOLUNTARY URINE LEAKAGE; THE CATHETER HAD DISLODGED; UPON ARRIVAL, THE PHYSICIAN FOUND THAT THE CATHETER BALLOON HAD RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520732 ↗
• MalfunctionMay 22, 2026Complete Blockage

  IT WAS REPORTED THAT; THE SIDE HOLES WERE CLOGGED DURING THE FLUSH PROCESS THE SIDE PORTS BECAME BLOCKED FIVE TIMES IN A ROW. MATERIAL NUMBER: 123420C, (LOT NO: MYJX5885). THE HOSPITAL CURRENTLY HAS (B)(4) UNITS OF THIS LOT. THE DEPARTMENT HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND REPORTS NO ISSUES WITH ITS OPERATION. PLEASE INVESTIGATE THE ROOT CAUSE OF THE PROBLEM TO AVOID DAMAGING THE PRODUCT¿S REPUTATION WITHIN THE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263012 ↗