Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 00801741034145), received between Apr 3, 2019 and Sep 30, 2026 — classified as 6 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (96 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 234 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952619 ↗
• MalfunctionJun 25, 2026Inflation Problem

  INSERTED CATHETER AS THE BALLOON WAS BEING INFLATED THE WATER CAME OUT AND THE TOP WHITE CONNECTOR CAME AWAY FROM THE CATHETER. THE SYRINGE IS RESISTING WHEN PUSHING DOWN ON IT ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25628390 ↗
• MalfunctionJun 25, 2026Material Puncture/Hole

  INSERTED CATHETER AS THE BALLOON WAS BEING INFLATED THE WATER CAME OUT AND THE TOP WHITE CONNECTOR CAME AWAY FROM THE CATHETER. THE SYRINGE IS RESISTING WHEN PUSHING DOWN ON IT ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626475 ↗
• MalfunctionMay 15, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER TRAY12CH MALE STANDARD 40CM NELATON TIP HYDROGEL COATED SILICONE WITH 10ML BALLOON FOR LONG TERM OF 3 MONTHS WITH URINE METER. THE PATIENT WAS BEING CATHETERIZED AND THE SURGEON ASKED FOR A NEW CATHETER BECAUSE THE BALLOON POPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191368 ↗
• MalfunctionMay 15, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT RECENTLY USED A 12 FR FOLEY CATHETER FOR A MALE PATIENT AND WAS COMPETENT AT MALE CATHETERIZATION'S AND EVERYTHING WENT SMOOTHLY. IT HAD BEEN TOLD TODAY THAT THE PATIENTS CATHETER FELL OUT BECAUSE THE BALLOON WAS NOT INFLATED, BUT IT WAS KNOWN THAT IT WAS BECAUSE CHECKED THERE WAS RESISTANCE ON THE CATHETER FROM THE BLADDER. THE BATCH NUMBER OF THE CATHETER WAS: NGJY2369, REF TR17585M12. THE REPORTER BELIEVE THEY HAVE MORE IN STOCK ROOM, IF THESE ARE FAULTY, PLEASE LET THEM KNOW AND THEY WILL ARRANGE FOR THEM TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188542 ↗
• MalfunctionMay 8, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BUSTED WHEN FILLING THE BALLOON CHAMBER WITH FLUID (NORMAL SALINE) WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129707 ↗
• MalfunctionApr 30, 2026Inflation Problem

  IT WAS REPORTED THAT WHILE INJECTING METHYLENE BLUE INTO PATIENTS URINARY FOLEY CATHETER, THE CATHETER FELL OUT OF THE PATIENT'S URETHRA, BALLOON WAS NOT INFLATED. ADVISED SURGEON, REPLACED URINARY CATHETER, PROCEEDED WITH INJECTING METHYLENE BLUE INTO BLADDER KEPT ORIGINAL CATHETER, TESTED BALLOON, BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045480 ↗
• MalfunctionApr 1, 2026Material Rupture

  IT WAS REPORTED THAT REGISTERED NURSE ATTEMPTED TO INSERT FOLEY CATHETER WITH THE ASSISTANCE OF REGISTERED NURSE. ON FILLING UP THE BALLOON WITH 8ML OF STERILE WATER A POP WAS HEARD BY THEMSELF, REGISTERED NURSE AND THE PATIENT. UPON FEELING IF THE CATHETER WAS IN PLACE, THAT FELT SECURE. HOWEVER, WHEN THEY ATTACHED THE BAG TO THE CATHETER, THE CATHETER CAME OUT WITH EASE, THE BALLOON WAS DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758846 ↗
• MalfunctionMar 25, 2026Material Rupture

  IT WAS REPORTED THAT CATHETER BALLOON FAILED UPON INFLATING AND BURST AND DRAINED INTO CATHETER BAG. CATHETER REMOVED AND INSPECTED. TRIED TO INFLATE BALLOON OUTSIDE OF PATIENT BUT COULD NOT. NEW CATHETER OPENED AND INSERTED INTO PATIENT. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690503 ↗
• MalfunctionMar 24, 2026Partial Blockage; Material Rupture

  IT WAS REPORTED THAT ON VISITING THIS PATIENT FOR A BLOCKED FOLEY CATHETER, WHEN INSERTING THE NEW CATHETER AND INFLATING THE BALLOON A POPPING NOISE WAS HEARD AND URINE WAS SEEN IN THE 10ML INFLATING SYRINGE, PERMISSION GAINED TO REMOVE CATHETER AND ON CLOSE INSPECTION OF THE CATHETER AND IT APPEARS THE BALLOON HAD POPPED AND WOULD NOT INFLATE THEREFORE IS WAS IDENTIFIED AS A FAULTY CATHETER, CATHETER DETAILS LUBRI-SIL BARD TRAY 12CH LOT-NGKT3823 EXP-10/12/2027, NEW CATHETER INSERTED WITH NIL ISSUES NO HARM CAME TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683051 ↗
• MalfunctionMar 24, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT DATIX 1: THE FOLEY CATHETER BALLOON HAD DEFLATED AND, DATIX 2: UNABLE TO INFLATE BALLOON, DATIX 3: UC NOT DRAINING, UNABLE TO DEFLATE BALLOON FULLY AND, DATIX 4: WATER FOR BALLOON REDIRECTED TO CATHETER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680488 ↗
• MalfunctionMar 24, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD ISSUE WHEN INFLATING BALLOON WITH 10MLS OF WATER WHICH WAS INCLUDED IN THE TRAY AND THE BALLOON APPARENTLY 'POPPED'. NEW CATHETER REINSERTED. IT ADVISED TO CONTACT YOU REGARDING TWO INCIDENTS THAT WERE RAISED CONCERNING DEFECTIVE CATHETERS. ON VISITING THIS PATIENT FOR A BLOCKED CATHETER, WHEN INSERTING THE NEW CATHETER AND INFLATING THE BALLOON A POPPING NOISE WAS HEARD AND URINE WAS SEEN IN THE 10ML INFLATING SYRINGE, PERMISSION GAINED TO REMOVE CATHETER AND ON CLOSE INSPECTION OF THE CATHETER IT APPEARS THE BALLOON HAD POPPED AND WOULD NOT INFLATE THEREFORE IS WAS IDENTIFIED AS A FAULTY CATHETER, CATHETER DETAILS LUBRI-SIL BARD TRAY 12CH LOT-NGKT3823 EXP-10/12/2027, NEW CATHETER INSERTED WITH NIL ISSUES NO HARM CAME TO PATIENT. UNFORTUNATELY, THE CATHETER WASN¿T RETAINED BY THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677168 ↗
• MalfunctionMar 24, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT DATIX 1: THE FOLEY CATHETER BALLOON HAD DEFLATED, DATIX 2: UNABLE TO INFLATE BALLOON, DATIX 3: UC NOT DRAINING, UNABLE TO DEFLATE BALLOON FULLY, DATIX 4: WATER FOR BALLOON REDIRECTED TO CATHETER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673894 ↗
• MalfunctionMar 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DATIX 1: THE FOLEY CATHETER BALLOON HAD DEFLATED (LOT#NGKV2767) AND LOT#NGKU2949), DATIX 2: UNABLE TO INFLATE BALLOON (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 3: UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 4: WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT#NGKV2767) AND (LOT#NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649612 ↗
• MalfunctionMar 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DATIX 1: THE FOLEY CATHETER BALLOON HAD DEFLATED (LOT#NGKV2767) AND LOT#NGKU2949), DATIX 2: UNABLE TO INFLATE BALLOON (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 3: UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 4: WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT#NGKV2767) AND (LOT#NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649589 ↗
• MalfunctionMar 19, 2026Difficult to Remove

  IT WAS REPORTED THAT DATIX 1: THE FOLEY CATHETER BALLOON HAD DEFLATED (LOT#NGKV2767) AND LOT#NGKU2949), DATIX 2: UNABLE TO INFLATE BALLOON (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 3: UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 4: WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT#NGKV2767) AND (LOT#NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644391 ↗
• MalfunctionMar 19, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DATIX 1: THE FOLEY CATHETER BALLOON HAD DEFLATED (LOT#NGKV2767) AND LOT#NGKU2949), DATIX 2: UNABLE TO INFLATE BALLOON (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 3: UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT#NGKV2767) AND (LOT#NGKU2949), DATIX 4: WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT#NGKV2767) AND (LOT#NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644390 ↗
• MalfunctionMar 19, 2026Inflation Problem

  IT WAS REPORTED THAT DATIX 1 THE FOLEY CATHETER BALLOON HAD DEFLATION PROBLEM (LOT NGKV2767) AND (LOT NGKU2949), DATIX 2 UNABLE TO INFLATE BALLOON (LOT NGKV2767) AND (LOT NGKU2949), DATIX 3 UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT NGKV2767) AND (LOT NGKU2949), DATIX 4 WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT NGKV2767) AND (LOT NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644083 ↗
• MalfunctionMar 19, 2026Inflation Problem

  IT WAS REPORTED THAT DATIX 1 THE FOLEY CATHETER BALLOON HAD DEFLATION PROBLEM (LOT NGKV2767) AND (LOT NGKU2949), DATIX 2 UNABLE TO INFLATE BALLOON (LOT NGKV2767) AND (LOT NGKU2949), DATIX 3 UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT NGKV2767) AND (LOT NGKU2949), DATIX 4 WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT NGKV2767) AND (LOT NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644063 ↗
• MalfunctionMar 19, 2026Difficult to Remove

  IT WAS REPORTED THAT DATIX 1 THE FOLEY CATHETER BALLOON HAD DEFLATION PROBLEM (LOT NGKV2767) AND (LOT NGKU2949), DATIX 2 UNABLE TO INFLATE BALLOON (LOT NGKV2767) AND (LOT NGKU2949), DATIX 3 UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT NGKV2767) AND (LOT NGKU2949), DATIX 4 WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT NGKV2767) AND (LOT NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644061 ↗
• MalfunctionMar 19, 2026Deflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DATIX 1 THE FOLEY CATHETER BALLOON HAD DEFLATION PROBLEM (LOT NGKV2767) AND (LOT NGKU2949), DATIX 2 UNABLE TO INFLATE BALLOON (LOT NGKV2767) AND (LOT NGKU2949), DATIX 3 UC NOT DRAINING UNABLE TO DEFLATE BALLOON FULLY (LOT NGKV2767) AND (LOT NGKU2949), DATIX 4 WATER FOR BALLOON REDIRECTED TO CATHETER TUBE (LOT NGKV2767) AND (LOT NGKU2949).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644060 ↗
• MalfunctionMar 18, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING PATIENT HANDLING, THE URETHRAL CATHETER WAS FOUND DISPLACED IN THE BED, AND UPON EXAMINATION THE BALLOON REPEATEDLY DEFLATED AFTER REINFLATION INDICATING A LEAK; FURTHER INVESTIGATION SUGGESTED A LUMEN-TO-LUMEN LEAK, THE CATHETER WAS REPLACED AS A REMEDIAL ACTION, AND THE ISSUE WAS NOTED TO BE RECURRENT WITH THIS PRODUCT. REMEDIAL ACTIONS: REPLACED CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631486 ↗
• MalfunctionMar 17, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER INFLATING PORT HAD BROKEN AND IT GOT DELATED, THE FOLEY CATHETER BALLOON BURST DURING INFLATION AND HAD SELF REMOVAL, UC SNAPPED. THE CLINICAL GUIDANCE REQUIRED ¿ EG PATIENT SAFETY ADVICE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 17MAR2026, STATED THAT DURING USE (LOT#NGJW3336- EVENT OCCURRED: 05JAN2026), (LOT#NGJX1067- EVENT OCCURRED: 14JAN2026) AND (LOT#NGJX1067- EVENT OCCURRED: 27JAN2026).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622362 ↗
• MalfunctionMar 17, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER INFLATING PORT HAD BROKEN AND IT GOT DELATED, THE FOLEY CATHETER BALLOON BURST DURING INFLATION AND HAD SELF REMOVAL, UC SNAPPED. THE CLINICAL GUIDANCE REQUIRED ¿ EG PATIENT SAFETY ADVICE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 17MAR2026, STATED THAT DURING USE (LOT#NGJW3336- EVENT OCCURRED: (B)(6) 2026), (LOT#NGJX1067- EVENT OCCURRED: (B)(6) 2026) AND (LOT#NGJX1067- EVENT OCCURRED: (B)(6) 2026).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622356 ↗
• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER INFLATING PORT HAD BROKEN AND IT GOT DELATED, THE FOLEY CATHETER BALLOON BURST DURING INFLATION AND HAD SELF REMOVAL, UC SNAPPED. THE CLINICAL GUIDANCE REQUIRED ¿ EG PATIENT SAFETY ADVICE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 17MAR2026, STATED THAT DURING USE (LOT#NGJW3336- EVENT OCCURRED: (B)(6) 2026), (LOT#NGJX1067- EVENT OCCURRED: (B)(6) 2026) AND (LOT#NGJX1067- EVENT OCCURRED: (B)(6) 2026).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622355 ↗