Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741025341), received between Mar 5, 2018 and May 20, 2026 — classified as 6 injuries, 26 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A SLICE IN THE SILICONE COUDE CATHETER AFTER IT WAS PUT IN THE STATLOCK AND THEY HAVE NOTICED THAT THE CATHETER WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231376 ↗
• MalfunctionJan 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER PLACED BY RN. BALLOON INFLATED AND PLACEMENT VERIFIED BY ANOTHER RN. RETURNED TO PATIENT'S ROOM. FOLEY WAS OUT AND BALLOON DEFLATED. FOLEY REPLACED WITH DIFFERENT LOT NUMBER. THEY KINDLY REQUESTED THE TEAM TO REVIEW THIS ISSUE AND ADVISE ON THE APPROPRIATE NEXT STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032146 ↗
• InjuryDec 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAS RECENTLY EXPERIENCED ISSUES WITH SEVERAL SIZES OF THE FOLEY CATHETERS. THE PART NUMBERS AND LOTS ARE AS FOLLOWS: 0170SI16 - LOT # NGKP4358 X12, 0170SI12 -LOT# NGKS1584 X1 AND 0170SI14 -LOT # NGKU4004¿X3. PATIENT WENT TO LITTLE FALLS EMERGENCY ROOM DUE TO FOLEY CATHETER COMING OUT ON (B)(6) 2025. NEW FOLEY CATHETER WAS PLACED AT LITTLE FALLS EMERGENCY ROOM. PATIENT THEN CAME TO ST. CLOUD HOSPITAL EMERGENCY ROOM ON (B)(6) 2025, DUE TO SIMILAR ISSUE CATHETER FALLING OUT (PER PATIENT HEARD HISSING SOUND THEN CATHETER CAME OUT). NEW CATHETER WAS PLACED 14 FRENCH COUDE. ON (B)(6) 2025, PATIENT CAME BACK TO EMERGENCY ROOM DUE TO CATHETER COMING OUT AGAIN AT HOME. ANOTHER NEW 14 FR COUDE WAS PLACED. WHEN PATIENT WAS ABOUT TO LEAVE THE EMERGENCY ROOM, THEY HEARD HISSING SOUND ONCE AGAIN AND CATHETER CAME OUT. ANOTHER NEW 14 FR COUDE WAS PLACED. THIS CATHETER LASTED TILL (B)(6) 2025, CATHETER CAME OUT ONCE AGAIN. DUE TO ISSUES WITH 14 FR COUDE CATHETER SILICONE, THEY PLACED A 16 FR COUDE SILICONE IN HOPES SAME ISSUE DOESN'T OCCUR AGAIN. NOT EVEN 24 HOURS LATER ON (B)(6) PATIENT CAME BACK FOR CATHETER ONCE AGAIN COMING OUT. DUE TO ISSUES WITH SILICONE CAT

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

  MAUDE report 23865665 ↗
• MalfunctionNov 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619760 ↗
• MalfunctionOct 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT HAD MULTIPLE RUPTURE OF THE FOLEY CATHETER BALLOONS. PATIENT HAD A CONCERN OF A MANUFACTURING DEFECT, NO CONCERNS WITH CARE RECEIVED. CATHETER BALLOONS ONLY INFLATED TO 10ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347637 ↗
• MalfunctionOct 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE RUPTURE OF THE CATHETER BALLOONS, LOOKS TO BE A 16F COUDE FOR EACH VISIT ON (B)(6) 2025 PATIENT HAD A CONCERN OF A MANUFACTURING DEFECT, NO CONCERNS WITH CARE RECEIVED. CATHETER BALLOONS ONLY INFLATED TO 10ML. PATIENT CODE: 4582. DEVICE CODE: 1310, 1546. REFERENCE REPORTS: MW5176227 AND MW5176228.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337715 ↗
• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE RUPTURE OF THE CATHETER BALLOONS. LOOKS TO BE A 16F COUDE FOR EACH VISIT ON (B)(6) 2025. PATIENT HAD A CONCERN OF A MANUFACTURING DEFECT, NO CONCERNS WITH CARE RECEIVED. CATHETER BALLOONS ONLY INFLATED TO 10ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324557 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT CUSTOMER SAID THE FOLEY CATHETER BALLOON JUST BURST WHEN THEY WERE INFLATING. TRYING TO GET MORE INFORMATION STILL BUT NO RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893627 ↗
• MalfunctionJul 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON (B)(6) 2025, PATIENT MRN# (B)(6) WAS BROUGHT TO OR ROOM #1 FOR A CYSTOSCOPY AND INSERT URETERAL CATHETERS BY THE PHYSICIAN AND A LAPAROSCOPIC LOW ANTERIOR RECTUM RESECTION BY ANOTHER PHYSICIAN. DURING THE CYSTOSCOPY PHYSICIAN WAS UNABLE TO INSERT THE URETERAL CATHETERS BUT WAS ABLE TO PLACE AN 18 FRENCH FOLEY REF# A303418A. AT THE START OF THE PART OF THE PROCEDURE THE FOLEY DID NOT STAY IN THE PATIENT AND FELL OUT OF THE PATIENT. ON REQUEST OF THE PHYSICIAN ANOTHER FOLEY WAS BROUGHT INTO THE ROOM AND PLACED IN THE PATIENT. THAT WAS A 16 FRENCH FOLEY REF# A303416A, AS THE PROCEDURE WAS GOING ON THAT FOLEY FELL OUT AS WELL. TWO MORE 16 FRENCH FOLEYS WERE PLACED REF# A303416A WITH THE SAME RESULTS. AND THEN ATTEMPTED TO PLACE A 16 FRENCH 2WAY COUDE REF# 0170SI16 AND A 18 FRENCH 2WAY COUDE REF# 0102L18 WITH THE SAME RESULTS. PHYSICIAN WAS ASKED TO ASSIST AT THIS POINT AND WAS ABLE TO SUCCESSFULLY PLACE A 20 FRENCH 2WAY COUDE REF# 0102L20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398287 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT ONE CONTINUOUS PIECE, AND THE WHITE TIP COULD BE ACCIDENTALLY BROKEN OFF OR SNAPPED WITH VERY LITTLE EFFORT. THIS WAS A SAFETY CONCERN PARTICULARLY SINCE THE TIP COULD POTENTIALLY BE RETAINED UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168031 ↗
• MalfunctionApr 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT COUDE FOLEY CATHETER CAME OUT OF PATIENT. SECOND FOLEY TO COME OUT OF PATIENT. UPON INSPECTING, BALLOON ON BOTH APPEARED TO HAVE RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848918 ↗
• MalfunctionApr 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THERE WAS BALLOON BURST ON COUDE FOLEY CATHETER, IT HAD OCCURRED ON 3 DIFFERENT FOLEYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841303 ↗
• MalfunctionApr 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT COUDE FOLEY CATHETER HAD BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840858 ↗
• MalfunctionApr 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT COUDE FOLEY CATHETER BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840848 ↗
• MalfunctionJan 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY COUDE CATHETER INSERTED DURING NIGHT SHIFT FROM (B)(6) 2024 TO (B)(6) 2024. FOLEY CATHETER WAS LEAKING SIGNIFICANTLY DURING PHYSICAL THERAPY. NURSE DEFLATED BALLOON, 9 MILLILITER OF NORMAL SALINE CAME OUT. NURSE REINFLATED BALLOON AND GENTLY PULLED BACK TO CONFIRM BALLOON INFLATION. THE CATHETER CAME ALL THE WAY OUT AT THAT POINT AND THE BALLOON WAS NOT INFLATED. IT APPEARED THE BALLOON HAD A LEAK OR TEAR DURING THE RE-INFLATION ATTEMPT. UNFORTUNATELY, THEY WERE NOT ABLE TO OBTAIN A LOT NUMBER AS THE PACKAGING WAS DISPOSED OF DURING THE NIGHT SHIFT TRASH TAKEOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209324 ↗
• MalfunctionOct 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER WAS PLACED IN THE OPERATING ROOM PRIOR TO SURGERY BALLOON WAS INFLATED WITH STERILE WATER. AFTER INSERTION, FOLEY WAS BEING POSITIONED AND CAME OUT ON POSITIONING. THE BALLOON WAS TESTED AFTER REMOVAL FROM THE PATIENT AND THE BALLOON WAS BROKEN OR NOT INTACT. NURSE CIRCULATOR NOTIFIED THE OPERATING ROOM CHARGE NURSE AND MANAGER THAT THE FOLEY BALLOON EITHER BROKE DURING INFLATION OR WAS ALREADY NOT INTACT PRIOR TO INFLATION. CHARGE AND MANAGER TOLD THE NURSE CIRCULATOR TO PROCEED WITH PLACING A NEW FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371455 ↗
• InjuryDec 15, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT SAID THIS WAS NOT THE CORRECT CATHETER AND THESE SILICONE COUDE FOLEY CATHETERS DID NOT WORK, AND THEY WERE HARD FOR THE PATIENT TO USE. PATIENT¿S DOCTOR HAD TO USE A WIRE TO INSERT THE CATHETERS IN PLACE. THE CATHETER THAT PATIENT NEEDED WERE ON BACK ORDER.

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

  MAUDE report 15988542 ↗
• InjurySep 24, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE HOSPITAL AND HAVE FOLEY CATHETER WAS LEAKING AND WAS CLOGGED UP. PATIENT WAS FOUND TO HAVE A URINARY TRACT INFECTION AND HAS BEEN PUT ON ANTI BIOTICS FOR TEN DAYS. PATIENT WAS CONCERNED IF DID NOT RECEIVE ORDER FOR LEG BAG IT WOULD PROLONG INFECTION. PER ADDITIONAL INFORMATION RECEIVED VIA FOLLOW-UP ON 19-SEP-2022, IT WAS STATED THAT THE HOSPITAL STAFF CONCLUDED THAT THERE WAS NOTHING WRONG WITH THE ACTUAL CATHETER BUT THAT IT HAD BEEN INSERTED INCORRECTLY INITIALLY AND THAT THEY BELIEVED THAT WAS WHAT LED TO THE BLOCKAGE AND URINARY TRACT INFECTION. CUSTOMER STATED THAT THEY DID HAVE TO BE ON AN ANTIBIOTIC BUT DID NOT KNOW THE NAME. CUSTOMER STATED THAT SINCE THEY WENT BACK TO UROLOGIST AND HAD ANOTHER CATHETER PLACED CORRECTLY AND HAS HAD NO FURTHER ISSUES.

  Patient problems: Urinary Tract Infection

  MAUDE report 15476536 ↗
• MalfunctionSep 15, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING THROUGH THE CATHETER BUT AROUND IT AND WAS GETTING SOAKED INSIDE THE TUBE BUT WAS NOT DRAINING INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432507 ↗
• InjuryFeb 28, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INSERT THE INTERMITTENT CATHETERS. PER CUSTOMER VIA PHONE ON (B)(6) 2022, IT WAS STATED THAT THE PATIENT WAS USING THE FOLEY CATHETERS INTERMITTENTLY AND HAD TROUBLE GETTING THEM INSERTED AS THE PATIENT HAD AN ARTIFICIAL BLADDER AND WHEN THEY DID NOT GO IN CORRECTLY, THE PATIENT EXPERIENCED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED. PATIENT WAS CURRENTLY USING FOLEY CATHETER BUT WAS USING INTERMITTENTLY. PATIENT HAD HOSPITALIZATION FOR URINARY TRACT INFECTION PRIOR TO CHANGING TO A DIFFERENT FOLEY CATHETER BUT THE CUSTOMER DID NOT BELIEVE THAT THE CATHETERS WERE THE CAUSE OF URINARY TRACT INFECTION. PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 13625860 ↗
• MalfunctionFeb 19, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED. STATED THAT IT ONLY HAD 8CC, WHEN THE CUSTOMER PUT 10CC IN IT. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PRODUCTS MORE THAN 90 DAYS. PER CARDINAL HEALTH EMAIL ON (B)(6) 2022, IT WAS REPORTED THAT THE CUSTOMER WAS ONLY ABLE TO PUT IN 8CC SALINE INSTEAD OF 10CC IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13565295 ↗
• MalfunctionSep 15, 2021Burst Container or Vessel; Failure to Infuse; Burst Container or Vessel; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE, WHEN ATTEMPTED TO INFLATE WITH SALINE. IT WAS ALSO NOTED THAT THERE WERE NO MISSING PIECES FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474322 ↗
• MalfunctionJun 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED SILICONE FOLEY CATHETER WAS JUNK AND CAUSED PATIENT TO GO TO THE HOSPITAL, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075161 ↗
• MalfunctionFeb 10, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT TWO BALLOON CATHETERS ALLEGEDLY DEFLATED AFTER SIX WEEKS OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11309187 ↗
• MalfunctionDec 18, 2020Disconnection; Decrease in Pressure; Disconnection; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE NOT STAYING IN PLACE. STATED IT MIGHT BE THE MATERIAL THAT WAS NOT ALLOWING THEM TO WORK. PER FOLLOW UP, THE CATHETER WAS DETACHING FROM THE BAG CAUSING URINE TO LEAK OUT. NO DEFLATION ISSUE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11039497 ↗