Bardex® Foley Catheter Silicone Coated 0167V24SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741019241), received between May 4, 2018 and Sep 26, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908460 ↗
• MalfunctionSep 26, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908454 ↗
• MalfunctionSep 4, 2026Material Puncture/Hole

  It was reported that leakage observed at the junction where the balloon lumen crosses the drainage lumen.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614141 ↗
• MalfunctionMar 11, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576465 ↗
• MalfunctionMar 9, 2026Inability to Irrigate; Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER IRRIGATION CHANNEL WAS NOT FUNCTIONING PROPERLY AND IT WAS ALSO CONTAMINATED WITH URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552014 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS BEDRIDDEN FOR A LONG TIME AND HAS AN INDWELLING FOLEY CATHETER. AFTER THE CATHETER WAS REPLACED ON (B)(6) 2026, THERE WAS CONTINUOUS URINE LEAKAGE FROM THE URETHRAL OPENING. AFTER REPORTING TO THE DOCTOR, CORRESPONDING MEASURES WERE TAKEN, BUT THE LEAKAGE PROBLEM COULD NOT BE RESOLVED. THE PATIENT'S SKIN HAS BEEN IN PROLONGED CONTACT WITH URINE, RESULTING IN SKIN DAMAGE IN THE SACROCOCCYGEAL AREA, CAUSING EMOTIONAL DISTRESS AND ANXIETY FOR BOTH THE PATIENT AND THEIR FAMILY. AFTER THE DOCTOR REINSERTED A NEW CATHETER FOR THE PATIENT, THE URINE LEAKAGE NO LONGER OCCURRED.

  Patient problems: Discomfort; Exposure to Body Fluids; Skin Inflammation/ Irritation

  MAUDE report 24422835 ↗
• MalfunctionApr 24, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINARY CATHETER DRAINAGE WAS NOT SMOOTH. AFTER THE URETHRAL FOLEY CATHETER WAS CONNECTED TO THE URINE BAG, THE DRAINAGE WAS NOT SMOOTH, AND THE SYRINGE WAS USED TO REVERSE THE IRRIGATION TO CONFIRM THAT THE PIPELINE WAS NOT BLOCKED, BUT THE DRAINAGE WAS STILL NOT SMOOTH, AND THE DRAINAGE CAN BE SMOOTH AFTER THE URETHRAL CATHETER WAS REPLACED, SO IT WAS SUSPECTED THAT THIS WAS A DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900336 ↗
• MalfunctionApr 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE SCRUB NURSE WAS TRYING TO INFLATE THE FOLEY CATHETER BALLOON BEFORE PASSING TO THE SURGEON, ONLY TO REALIZE THAT THE BALLOON COULD NOT INFLATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738148 ↗
• MalfunctionFeb 20, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT AFTER THE THREE-PRONGED URINARY FOLEY CATHETER WAS PLACED IN THE PATIENT'S BLADDER, THE DRAINAGE WAS NOT SMOOTH, AND THE TUBE WAS NOT BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422844 ↗
• MalfunctionDec 30, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS PRODUCT BARDIA SILICONE ELASTOMER COATED LATEX 3-WAY FOLEY CATHETER, 30CC, MALE, 24 FR BECAUSE OF PATIENT WAS AGITATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034865 ↗
• MalfunctionDec 24, 2024Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT THE FOLEY CATHETER HAS AN ABNORMAL STRUCTURE AT THE ANTERIOR END. WHEN THE FOLEY CATHETER WAS OPENED, IT WAS FOUND THAT THE ANTERIOR END OF THE CATHETER WAS ABNORMAL, AND THE ORIFICE SIZE WAS IRREGULAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011803 ↗
• MalfunctionDec 23, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT A URINARY FOLEY CATHETER WAS INSERTED, BUT THE DRAINAGE WAS NOT SMOOTH. AFTER REMOVAL, IT WAS CONFIRMED THAT THERE WAS NO VESSEL ENTRAPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000080 ↗
• MalfunctionSep 3, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE BALLOON AREA OF THE FOLEY CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26AUG2024, STATED THAT THE WATER BALLOON DID NOT RUPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126293 ↗
• MalfunctionJul 1, 2021Device Damaged Prior to Receipt by User; Component Misassembled; Device Damaged Prior to Receipt by User; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONE CS AND INSTEAD OF 12 EA BEING IN THE CASE THERE WAS ONLY 4 EA, AND THE CASE WAS SEALED. PER FOLLOW UP VIA PHONE ON 11JUN2021, CUSTOMER STATED THAT THEY ONLY RECEIVED FOUR CATHETERS INSTEAD OF A CASE FULL. THEY WERE IN A BOX THAT WAS NOT TAPED SHUT AND DID NOT APPEAR AS IF ANY TAPE HAD BEEN PULLED FROM IT. CUSTOMER REPORTED THE SAME ISSUE TO MEDLINE AS COULD NOT BE CERTAIN WHERE THE PROBLEM ORIGINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099745 ↗
• MalfunctionMay 22, 2020Burst Container or Vessel; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED WHEN ATTEMPTING TO DEFLATE A FOLEY CATHETER BALLOON. NO FLUID WAS PRESENT IN THE BALLOON. THE BALLOON WAS PULLED AND THE CATHETER WAS FOUND TO HAVE A RUPTURED BALLOON.

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

  MAUDE report 10082648 ↗
• MalfunctionMay 4, 2018Misassembled; Misassembled; Positioning Problem

  IT WAS REPORTED THAT THE BALLOON ON THE CATHETER WAS FURTHER DOWN FROM THE TIP THAN USUAL.

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

  MAUDE report 7488579 ↗
• MalfunctionMay 4, 2018Misassembled; Inflation Problem; Misassembled

  IT WAS REPORTED THAT THE BALLOON ON THE CATHETER WAS FURTHER DOWN FROM THE TIP THAN USUAL. ALTHOUGH, THE CATHETER WAS NOT BEING USED FOR URINARY DRAINAGE INSTEAD IT WAS USED ON A PREGNANT WOMAN TO HELP RIPEN THE CERVIX. THE COMPLAINANT ALLEGED THAT THIS RESULTED IN "DIFFICULTY WITH PLACEMENT FOR CERVICAL OPENING." IT WAS LATER REPORTED THAT THE CATHETER WAS INSERTED INTO THE CERVIX AND THE BALLOON INFLATED. THIS CREATED TENSION ON THE CERVIX AND CAUSED THE RELEASE OF PROSTAGLANDINS. THIS HELPS THE CERVIX "RIPEN". (B)(6) RN.

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

  MAUDE report 7488450 ↗