Bardex® Silicone Coated Foley Catheter 0166V16SRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741039492), received between Nov 30, 2021 and Sep 5, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2026Material Invagination; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50634878 ↗
• MalfunctionJul 10, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787473 ↗
• InjuryJun 11, 2026Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF CEREBRAL HEMORRHAGE, AND AFTER ADMISSION, THE CATHETER WAS REMOVED ON (B)(6) 2026, AND IT WAS FOUND THAT FLUID COULD NOT BE WITHDRAWN FROM THE BALLOON. TO RULE OUT THE CAUSE, WITHOUT VIOLENCE, HE WAS GIVEN AN IMMEDIATE REPLACEMENT OF STERILE SCISSORS TO CUT OFF THE END OF THE BALLOON IN ORDER TO REMOVE THE URINARY CATHETER.

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

  MAUDE report 25479042 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING INTRAOPERATIVE INDWELLING OF THE URINARY FOLEY CATHETER, THE PATIENT'S URINE MAY NOT BE ABLE TO BE EXPELLED DUE TO BALLOON LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144083 ↗
• MalfunctionMar 24, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2026, AT 09:15, THE DOCTOR FOUND THAT THE FOLEY CATHETER BALLOON RUPTURED WHEN REMOVING THE TUBE AT THE BEDSIDE. THERE WAS NO RESIDUE IN THE PATIENT'S BODY, AND THE PATIENT DID NOT REPORT ANY DISCOMFORT. A CATHETER WAS SUBSEQUENTLY REPLACED AT THE BEDSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682737 ↗
• MalfunctionJan 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE, LEAKAGE OCCURRED IN THE FOLEY CATHETER. REPLACED WITH SECONDARY CATHETER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103160 ↗
• MalfunctionJan 14, 2026Material Rupture

  IT WAS REPORTED THAT, AFTER DRAINING URINE FROM THE PATIENT, THE URINARY FOLEY CATHETER WAS REMOVED, REVEALING A RUPTURED WATER BLADDER. IMMEDIATELY INSPECT THE CATHETER FOR INTEGRITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070252 ↗
• MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ONE PACKAGE OF 8 URINARY CATHETERS CONTAINED SHREDDED PAPER AND ONE PRODUCT EXHIBITED AIR LEAKAGE. (125816C- LOT # MYHW3462- (OCCURRENCE 1)), (123614C- LOT # MYHT0905 (OCCURRENCE 1), (125818C- LOT # MYGV4245 (OCCURRENCE 4)), (123422C-LOT # MYGY4017 (OCCURRENCE 3).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929060 ↗
• MalfunctionDec 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT, THE WATER IN THE BALLOON OF THE FOLEY CATHETER FLUID COULD NOT BE PUMPED BACK OUT DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772202 ↗
• MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT, AFTER INSERTING THE URINARY FOLEY CATHETER, THE PHYSICIAN DISCOVERED A LEAK AT THE CATHETER SITE AND IMMEDIATELY REMOVED AND REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771830 ↗
• MalfunctionNov 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER BALLOON WAS INFLATED AND THE SYRINGE WAS WITHDRAWN, THE RUBBER CONNECTION BETWEEN THE BALLOON AND THE SYRINGE DETACHES AND BREAKS. REPLACED THE URINARY CATHETER AND REINSERTED THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619214 ↗
• MalfunctionOct 28, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BEFORE REINSERTING THE URINARY FOLEY CATHETER, WHEN TESTING THE BALLOON, THE BALLOON COULD NOT BE WITHDRAWN AFTER BEING FILLED WITH SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403718 ↗
• MalfunctionOct 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT, AFTER ACUTE CEREBRAL INFARCTION SURGERY, HAD LONG-TERM INDWELLING CATHETERIZATION TO MAINTAIN DRAINAGE TUBE PATENCY. ON (B)(6) 2025, DURING THE REPLACEMENT OF THE FOLEY CATHETER, THE CONNECTION PART OF THE CATHETER INFLATION PORT BECAME DISCONNECTED. NO ADVERSE OUTCOMES OCCURRED, AND THE CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337601 ↗
• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE SALINE INJECTION TEST TO VERIFY THE FOLEY CATHETER BALLOON INTEGRITY PRIOR TO CATHETERIZATION, THE BALLOON DETACHED. THIS WAS IMMEDIATELY REPORTED TO THE OPERATING ROOM STAFF, WHO REPLACED THE CATHETER. THE INCIDENT WAS SUBSEQUENTLY ESCALATED THROUGH THE CHAIN OF COMMAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002911 ↗
• MalfunctionAug 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT; THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH FEVER AND POOR APPETITE FOR ONE DAY. AFTER ADMISSION, THE URINARY FOLEY CATHETER EXPIRED AND WAS REPLACED AS PRESCRIBED. THE PATIENT HAD A HISTORY OF URINARY RETENTION. WHEN REPLACING THE URINARY FOLEY CATHETER, IT WAS FOUND THAT THE WATER INJECTION HOLE ON THE CATHETER HAD COME OUT AND COULD NOT BE INJECTED WITH WATER. THE URINARY CATHETER COULD NOT BE FIXED, SO URINARY CATHETERIZATION WAS PERFORMED AFTER REPLACING THE URINARY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865054 ↗
• MalfunctionJul 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN THE DOCTOR USED A BARD CATHETER TO PERFORM AN ENEMA THROUGH THE STOMA, THE FOLEY CATHETER WATER BAG RUPTURED, CAUSED THE CATHETER TO FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588100 ↗
• MalfunctionJul 22, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CATHETERIZATION, THE FOLEY CATHETER WAS CHECKED, AND THE BALLOON WATER INJECTION POINT WAS FOUND TO BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563805 ↗
• MalfunctionJul 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE WATER BLADDER LEAKS IN FOLEY CATHETER WHEN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384653 ↗
• MalfunctionJul 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DIAGNOSIS OF URINARY RETENTION WAS CLEAR AND CATHETERIZATION AND INDWELLING CATHETERIZATION WERE RECOMMENDED TO IMPROVE SYMPTOMS. A URINARY FOLEY CATHETER WAS PLACED FROM (B)(6) 2025, AND WAS FOUND TO BE DISLODGED DURING BLADDER IRRIGATION, AND THE SUPRAPUBIC BALLOON DID NOT FILL UP AFTER FILLING WITH WATER. THE URINARY CATHETER BALLOON FLOWED OUT ON ITS OWN AFTER FILLING WITH WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383947 ↗
• MalfunctionJul 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE TEST OF THE FOLEY CATHETER, THE WATER BAG OF THE CATHETER RUPTURED AND THE FRONT PART OF THE CATHETER FELL OFF WHEN IT WAS PUMPED WITH WATER. MIGHT CAUSE URINARY RETENTION AND INCREASE RISK OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383931 ↗
• MalfunctionJun 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 19:10 ON (B)(6) 2025 DUE TO COUGHING AFTER EATING FOR 3 DAYS AND FEVER FOR 1 HOUR. THE DIAGNOSIS UPON ADMISSION WAS SEVERE PNEUMONIA AND TYPE I RESPIRATORY FAILURE. AT 19:15 ON (B)(6) 2025, THE NURSE FOUND THAT THE FOLEY CATHETER WATER BAG WAS LEAKING WHEN INSERTING A URINARY CATHETER INTO THE PATIENT. AFTER REPLACING THE NEW CATHETER, THE WATER BAG DID NOT LEAK, AND THE URINARY CATHETER WAS SUCCESSFULLY INSERTED WITHOUT ANY IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140768 ↗
• MalfunctionMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERAL ANESTHESIA ON (B)(6) 2025, FOR A URETERORENOSCOPY AND LASER LITHOTRIPSY FOR RENAL PELVIS STONE, WITH AN INDWELLING URINARY FOLEY CATHETER LEFT IN PLACE. ON (B)(6) 2025 AT 13:20, THE PATIENT¿S URINARY CATHETER SLIPPED OUT ON ITS OWN, WITH NO DAMAGE TO THE URETHRAL OPENING AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088216 ↗
• MalfunctionMay 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY CATHETER PLUG FELL OFF AFTER FILLING WITH WATER RECENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051782 ↗
• MalfunctionMay 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AT 15:14 DUE TO SUDDEN RIGHT LIMB WEAKNESS FOR 5 HOURS AND THE ADMISSION DIAGNOSIS WAS SPONTANEOUS CEREBRAL HEMORRHAGE. ON (B)(6) 2025 AT 15:40 THE NURSE FOUND THAT THE FOLEY CATHETER WATER BAG WAS LEAKING WHEN INSERTING THE CATHETER INTO THE PATIENT, SO THE WATER BAG DID NOT LEAK AFTER CHANGING THE NEW CATHETER, AND THE INDWELLING CATHETER WAS SUCCESSFUL, WITH NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950200 ↗
• MalfunctionMar 20, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 AT 10:20 BEFORE INSERTING A NO. 16 URINARY FOLEY CATHETER INTO THE PATIENT, THE BALLOON WAS TESTED TO SEE IF IT WAS INTACT. AFTER 13 ML OF SALINE WAS INJECTED INTO THE FOLEY CATHETER BALLOON, IT COULD NOT BE WITHDRAWN, CAUSING NO HARM TO THE PATIENT. THE CATHETER WAS REPLACED AND THEN INSERTED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653529 ↗