Bardex® Lubri-Sil® All-Silicone Foley Catheter 175806NRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741034268), received between Aug 21, 2017 and Sep 4, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614133 ↗
• MalfunctionApr 15, 2026Material Fragmentation

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS INSERTED, THE ENTIRE FOLEY BROKE BELOW THE ACCESS TO THE BALLOON PORT MAKING IT IMPOSSIBLE TO DEFLATE BALLOON WITH SYRINGE. FOLEY CAME OUT ON ITS OWN WITH BALLOON DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891568 ↗
• MalfunctionApr 14, 2026Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS FOUND SPLIT IN HALF ON THE BED DURING PATIENT ASSESSMENT, AND THE PRODUCT WAS AVAILABLE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879391 ↗
• MalfunctionMar 2, 2026Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT HAD BEEN TRANSFERRED BACK TO BED FROM A HOLD. WHILE LIFTING THE PATIENT, WETNESS HAD BEEN NOTICED. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE FOLEY CATHETER HAD BROKEN, AND URINE HAD BEEN THE CAUSE OF THE WETNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482771 ↗
• MalfunctionFeb 25, 2026Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED BY THE CUSTOMER THAT THE FOLEY CATHETER TUBING HAD BEEN LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447247 ↗
• MalfunctionJan 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING FOLEY CARE, A SMALL PUDDLE OF URINE WAS OBSERVED ON THE BLANKET BENEATH THE SECUREMENT DEVICE ATTACHING THE FOLEY TO THE LEG. THE FOLEY WAS REMOVED FROM THE DEVICE, AND A VERY SMALL HOLE WITH A SLOW LEAK WAS DISCOVERED. THE FOLEY WAS THEN REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171736 ↗
• MalfunctionSep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER STATED THE BALLOON WAS BROKEN INSIDE THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963465 ↗
• MalfunctionJul 23, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND INFLATION OF BALLOON WITH NO INCIDENT. UPON PULLING THE CATHETER TO CHECK THAT IT WAS SECURED BY THE BALLOON, IT SLID OUT COMPLETELY. A NEW CATHETER WAS INSERTED BY THE PHYSICIAN WITH NO INCIDENT. THEY TESTED THE DEFECTIVE BALLOON BY INFLATING WITH MORE SALINE TO FIND THE BALLOON WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576327 ↗
• MalfunctionMay 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON ASSESSMENT OF THE PATIENT, A FOLEY CATHETER WAS FOUND TO BE SPLIT IN HALF ON THE BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027431 ↗
• MalfunctionApr 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT LIKE THE OTHER SCENARIO DESCRIBED THE OTHER DAY, THE RESIDENT FELT RESISTANCE UPON FILLING THE BALLOON, BUT NO MENTION OF AN AUDIBLE POP IN THIS INSTANCE AND TEAM SAW FLUID FLOW. THEY NOTICED WHEN FOLEY SLIPPED OUT AND THEY REPLACED WITH ANOTHER WITH SAME LOT NUMBER AND WAS FINE. NEW FOLEY NEEDED TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925708 ↗
• MalfunctionApr 9, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE INDWELLING FOLEY CATHETER IN SITU, THE ENTIRE FOLEY BELOW THE ACCESS TO THE BALLOON PORT MAKING IT IMPOSSIBLE TO DEFLATE BALLOON TO SYRINGE. FOLEY CAME OUT ON ITS OWN WITH BALLOON DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805064 ↗
• MalfunctionJul 5, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED TO THE PATIENT AND THE BALLOON WAS INFLATED TO 5CC PER PACKAGING. THE CATHETER WAS PULLED LIGHTLY TO SEAT THE BALLOON IN THE BLADDER, BUT THE FOLEY SLIPPED OUT AND THE BALLOON WAS NOTED TO BE BROKEN. THE PATIENT WAS THEN CATHETERIZED SUCCESSFULLY WITH A DIFFERENT CATHETER WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916294 ↗
• MalfunctionMay 4, 2022Calcified; Calcified

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM THE BALLOON PORT OF THE FOLEY CATHETER. THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. THE BALLOON WAS NOTED TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP WHEN THE FOLEY CATHETER WAS REMOVED. A NEW FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS AND IT WAS UNABLE TO DETERMINE IF PARTS OF THE BALLOON WAS REMAINING IN THE PATIENT. IT WAS STATED THAT THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272636 ↗
• MalfunctionApr 29, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM THE BALLOON PORT OF THE FOLEY CATHETER. THE USER ATTEMPTED TO ASPIRATE FROM THE BALLOON PORT FOR SMALL AMOUNT OF URINE. THE BALLOON WAS NOTED TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP WHEN THE FOLEY CATHETER WAS REMOVED. A NEW FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS AND IT WAS UNABLE TO DETERMINE IF THE PARTS OF THE BALLOON WAS REMAINING IN THE PATIENT. IT WAS STATED THAT THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254475 ↗
• MalfunctionApr 27, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM THE BALLOON PORT OF THE FOLEY CATHETER. THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. THE BALLOON WAS NOTED TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP WHEN THE FOLEY CATHETER WAS REMOVED. A NEW FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS AND IT WAS UNABLE TO DETERMINE IF PARTS OF THE BALLOON WAS REMAINING IN THE PATIENT. IT WAS STATED THAT THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218830 ↗
• MalfunctionApr 19, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM BALLOON PORT OF FOLEY CATHETER. THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. THE BALLOON WAS FOUND TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP WHEN THE FOLEY CATHETER WAS REMOVED. THERE WERE NO COMPLICATIONS WHEN ANOTHER FOLEY CATHETER WAS PLACED. THE USER WAS NOT ABLE TO DETERMINE WHETHER THE PARTS OF BALLOON REMAINED INSIDE THE PATIENT, AND IT WAS NOTED THAT THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141382 ↗
• MalfunctionApr 19, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM BALLOON PORT OF FOLEY CATHETER. SO, THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. WHEN THE FOLEY CATHETER WAS REMOVED, THE BALLOON WAS FOUND TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP. ANOTHER FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS. THE USER WAS NOT ABLE TO DETERMINE WHETHER PARTS OF BALLOON REMAINED INSIDE THE PATIENT. IT WAS STATED THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141222 ↗
• MalfunctionApr 14, 2022Calcified; Calcified

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM BALLOON PORT OF FOLEY CATHETER. SO, THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. WHEN THE FOLEY CATHETER WAS REMOVED, THE BALLOON WAS FOUND TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP. ANOTHER FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS. THE USER WAS NOT ABLE TO DETERMINE WHETHER PARTS OF BALLOON REMAINED INSIDE THE PATIENT. IT WAS STATED THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14114462 ↗
• MalfunctionApr 14, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM BALLOON PORT OF FOLEY CATHETER. THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. THE BALLOON WAS FOUND TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP WHEN THE FOLEY CATHETER WAS REMOVED. THERE WERE NO COMPLICATIONS WHEN ANOTHER FOLEY CATHETER WAS PLACED. THE USER WAS NOT ABLE TO DETERMINE WHETHER THE PARTS OF BALLOON REMAINED INSIDE THE PATIENT AND IT WAS NOTED THAT THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14114107 ↗
• MalfunctionApr 14, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM BALLOON PORT OF FOLEY CATHETER. SO, THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. WHEN THE FOLEY CATHETER WAS REMOVED, THE BALLOON WAS FOUND TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP. ANOTHER FOLEY CATHETER WAS PLACED WITH NO COMPLICATIONS. THE USER WAS NOT ABLE TO DETERMINE WHETHER PARTS OF BALLOON REMAINED INSIDE THE PATIENT. IT WAS STATED THE BALLOON MATERIAL APPEARS TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113637 ↗
• MalfunctionApr 14, 2022Calcified; Calcified

  IT WAS REPORTED THAT URINE WAS NOTED TO BE DRAINING FROM BALLOON PORT OF FOLEY CATHETER. THE USER ATTEMPTED TO ASPIRATE FROM BALLOON PORT FOR SMALL AMOUNT OF URINE. THE BALLOON WAS FOUND TO BE RUPTURED AND HAD SEDIMENTS ON THE TIP WHEN THE FOLEY CATHETER WAS REMOVED. THERE WERE NO COMPLICATIONS WHEN ANOTHER FOLEY CATHETER WAS PLACED. THE USER WAS NOT ABLE TO DETERMINE WHETHER THE PARTS OF BALLOON REMAINED INSIDE THE PATIENT AND IT WAS NOTED THAT THE BALLOON MATERIAL APPEARED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112708 ↗
• MalfunctionAug 10, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS RUPTURED.

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

  MAUDE report 12300556 ↗
• MalfunctionMay 21, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE SILICONE CATHETER PLACED AND BALLOON INFLATED TO 2 ML. THE PATIENT FELT IRRITABLE INTERMITTENTLY FOR NEXT TWO HOURS AND NO URINE COLLECTED IN CATHETER TUBING. IT WAS FURTHER STATED THAT THE BALLOON ATTEMPTED TO BE DEFLATED, BUT ONLY DROPS CAME OUT. AFTER THE PATIENT FINISHED VOIDING, SILICONE CATHETER REMOVED AND BALLOON FOUND TO BE BLOWN. PER FOLLOW UP WITH CUSTOMER VIA MAIL ON (B)(6) 2021, THERE WAS NO ADVERSE EVENT NOTED, EXCEPT THAT A NEW CATHETER HAD TO BE INSERTED.

  Patient problems: Irritability

  MAUDE report 11862960 ↗
• MalfunctionDec 21, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT TWO FOLEY CATHETERS WERE REMOVED FROM THE PACKAGING AND ALLEGEDLY THE BALLOONS APPEARED ROUGH OR RUPTURED. NO PATIENT INVOLVEMENT AS THIS WAS DETECTED PRIOR USE. IT WAS FURTHER REPORTED THAT THIS WAS AN RECURRING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11044465 ↗
• MalfunctionJun 25, 2020Burst Container or Vessel; Break; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON POPPED IN THE PATIENT UPON INFLATION. NO PIECES WERE REPORTED TO BE MISSING.

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

  MAUDE report 10194780 ↗