Bardex® Lubri-Sil® All-Silicone Foley Catheter 175808Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741034275), received between Aug 8, 2017 and Sep 3, 2026 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Difficult to Remove

  It was reported from New Brunswick on (b)(6) 2026 that an 8Fr Foley catheter (REF (b)(4), LOT NGKU0844) was inserted into a patient in the Pediatric Intensive Care Unit with 5 mL instilled into the balloon as per the product instructions. The catheter was subsequently removed due to the patient voiding around the Foley. When removal was attempted, the RN was unable to withdraw more than 4.2 mL from the balloon and encountered resistance during catheter removal. The physicians were notified, and manipulation under ultrasound guidance was required to facilitate removal of the Foley catheter. Upon removal, the balloon was observed to remain partially inflated on one side. No bleeding or swelling was noted in the patient.

  Patient problems: Insufficient Information

  MAUDE report 50578070 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINARY FOLEY HAD A SHAVED PIECE OF PLASTIC THAT STARTED TO LEAK FLUID FROM ONCE FOLEY WAS PLACED. THIS RESULTED IN THEM REMOVING THE FOLEY AND HAVING TO PLACE A NEW ONE. CAUSING A RISK FOR INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185884 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT URINARY FOLEY CATHETER HAD A SHAVED PIECE OF PLASTIC THAT STARTED TO LEAK FLUID FROM ONCE FOLEY WAS PLACED. THAT WAS RESULTED IN THEY REMOVED THE FOLEY AND HAD TO PLACE A NEW ONE. CAUSED A RISK FOR INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185414 ↗
• MalfunctionJan 14, 2026Material Rupture

  IT WAS REPORTED THAT, DURING PLACEMENT OF THE FOLEY CATHETER, THE BALLOON RUPTURED UPON SYRINGE ATTACHMENT AND INITIAL INFLATION. THE AFFECTED PRODUCT DID NOT HAVE A RECORDED LOT NUMBER AND WAS NOT RETAINED FOR FURTHER ANALYSIS. STAFF HAVE SINCE BEEN REEDUCATED TO PREVENT RECURRENCE. THIS INCIDENT OCCURRED IN THE MAIN OR AND IS THE FIRST OF ITS KIND REPORTED AT THIS LOCATION. IT REMAINS UNCLEAR WHETHER SIMILAR ISSUES HAVE BEEN OBSERVED AT NISWONGER, WHERE THIS PRODUCT IS PRIMARILY USED FOR PEDIATRIC PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073485 ↗
• MalfunctionDec 19, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY DISCOVERED THAT ALL OF OUR SUPPLY OF BARD LUBRI-SIL ALL-SILICONE FOLEY CATHETERS SIZES 8FR TO 20FR IN THE STOLLERY OR LEVEL 1 CORE HAVE LABELLING DISCREPANCIES. THE LOT NUMBER ON OUTSIDE OF PACKAGE DID NOT MATCH WITH LOT NUMBER ON PRODUCT INSIDE PACKAGE. THE BALLOON FILL AMOUNTS DO NOT MATCH ON THE 20FR AND 12FR PRODUCTS/PACKAGING. (THE REFERENCE NUMBERS DO APPEAR TO MATCH WITH PRODUCT AND PACKAGING). FOLEY CATHETER SIZE 8FR; FOLEY CATHETER SIZE 10FR; FOLEY CATHETER SIZE 12FR; FOLEY CATHETER SIZE 14FR; FOLEY CATHETER SIZE 16FR; FOLEY CATHETER SIZE 18FR; FOLEY CATHETER SIZE 20FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850896 ↗
• InjurySep 22, 2025Material Invagination; Material Invagination

  IT WAS REPORTED THAT WHEN REMOVING FOLEY CATHETER, THERE WAS RESISTANCE IN THE CATHETER DESPITE ALL OF WATER BEEN REMOVED FROM THE BALLOON. UROLOGY WAS CONSULTED THE FELLOW ADUREY STOUT REMOVED FOLEY. ONCE REMOVED THE CATHETER BALLOON SHOWED TO BE DEFECTIVE AND HAD INVERTED ON ITSELF. UROLOGY AWARE AND SAID NO NEED TO FOLLOW UP. REF NUMBER OF ITEM 175808. LOT NUMBER NGKS3922.

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

  MAUDE report 23110206 ↗
• MalfunctionJul 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE INSERTED FOLEY CATHETER WAS LEAKED AT THE LUMEN CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396906 ↗
• MalfunctionJun 26, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS LEAKING OUT THROUGH THE TIP OF THE FOLEY WHILE THEY WERE TESTING IT PRIOR TO PLACING IT ON THE PATIENT. SO, THEY JUST OPENED A NEW ONE AND PLACED IT ON THE PATIENT WITHOUT ANY EVENTS. PER CUSTOMER FOLLOW UP RECEIVED VIA MAIL ON 26JUN2025, IT WAS REPORTED THAT WHILE PLACED IN PATIENT BALLOON FILLED THE PACKAGE SPECIFIED MLS, THEN SLIPPED OUT. BALLOON THEN TESTED ON BACK TABLE AND FOUND TO BE LEAKING OUT THROUGH THE TIP OF THE FOLEY. NEW FOLEY OPENED FOR PATIENT AND WAS SUCCESSFULLY PLACED. THEY JUST CHANGED THE FOLEY WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337329 ↗
• MalfunctionMay 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER RANG CALL BELL AT 0645 TO REPORT PATIENT CATHETER HAD BROKEN. UPON INSPECTION IT APPEARED THAT APPROXIMATELY 2 TO 3 INCHES BELOW WHERE THE CATHETER WAS SECURED TO PATIENT LEG, THE CATHETER WAS COMPLETELY SEVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960324 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON INSERTING WATER, THERE WAS LEAKING AT THE HUB. NEW FOLEY CATHETER NEEDED TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926587 ↗
• MalfunctionDec 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE OPERATING ROOM HAD REPORTED THREE INCIDENTS WITHIN A ONE-WEEK PERIOD. NO FURTHER OCCURRENCES HAVE BEEN NOTED SINCE LAST WEDNESDAY. IN TWO OF THE INCIDENTS, THROUGH DIFFERENT PROCEDURES WITH SEPARATE STAFF, THE BALLOON RUPTURED AFTER INSERTION. IN THE THIRD INCIDENT, AS A PRECAUTION, THE INDIVIDUAL TESTED THE BALLOON PRIOR TO INSERTION, AND IT WOULD NOT DEFLATE. THEY JUST REPORTED THAT THEY ENCOUNTERED ANOTHER FOLEY ISSUE. FOLEY WAS REMOVED AND A DIFFERENT FOLEY NEEDED TO BE INSERTED. THE CUSTOMER WONDERS IF THEY PUSHED THE WATER SYRINGE IN FAR ENOUGH TO ENGAGE THE VALVE IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018514 ↗
• MalfunctionDec 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE OPERATING ROOM HAD REPORTED THREE INCIDENTS WITHIN A ONE-WEEK PERIOD. NO FURTHER OCCURRENCES HAVE BEEN NOTED SINCE LAST WEDNESDAY. IN TWO OF THE INCIDENTS, THROUGH DIFFERENT PROCEDURES WITH SEPARATE STAFF, THE BALLOON RUPTURED AFTER INSERTION. IN THE THIRD INCIDENT, AS A PRECAUTION, THE INDIVIDUAL TESTED THE BALLOON PRIOR TO INSERTION, AND IT WOULD NOT DEFLATE. THEY JUST REPORTED THAT THEY ENCOUNTERED ANOTHER FOLEY ISSUE. FOLEY WAS REMOVED AND A DIFFERENT FOLEY NEEDED TO BE INSERTED. THE CUSTOMER WONDERS IF THEY PUSHED THE WATER SYRINGE IN FAR ENOUGH TO ENGAGE THE VALVE IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20999833 ↗
• MalfunctionOct 4, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLEY CATHETER WAS BROKEN WITHIN KIT, AND IT WAS DISCOVERED UPON INSERTION. ANOTHER FOLEY WAS USED WITHOUT INCIDENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372638 ↗
• MalfunctionSep 16, 2024

  8F FOLEY KIT #175808, NGFS0787, FOLEY BROKEN WITHIN KIT, DISCOVERED UPON INSERTION. ANOTHER FOLEY WAS USED WITHOUT INCIDENT. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223465 ↗
• MalfunctionDec 30, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER FOUND IN BED BROKEN OFF AT HUB. ALSO STATED THAT CATHETER STILL INSITU AND WELL SECURED WITH SECURING DEVICE. BALLOON HAD DEFLATED THROUGH OPEN LUMEN AND REMOVED EASILY WITHOUT RESISTANCE. PER NOTIFICATION RECEIVED ON 13DEC2022, IT WAS NOTED THAT THE FOLEY CATHETER WITH MATERIAL # 175808 WAS RECEIVED FOR SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077875 ↗
• MalfunctionNov 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON INSERTING THE FOLEY CATHETER URINE WAS FOUND LEAKING THROUGH BREAK IN THE CATHETER DIRECTLY ABOVE THE RED TAPE THAT SECURES THE CATHETER TO THE DRAINAGE BAG TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727713 ↗
• MalfunctionNov 4, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON INSERTING THE FOLEY CATHETER URINE WAS FOUND LEAKING THROUGH BREAK IN THE CATHETER DIRECTLY ABOVE THE RED TAPE THAT SECURES THE CATHETER TO THE DRAINAGE BAG TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726342 ↗
• MalfunctionJun 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT WAS FOUND WITH FOLEY CATHETER OUT IN DIAPER. STATED THAT THE CATHETER WAS INTACT AND THE BALLOON DEFLATED. THE BALLOON HAD A VERTICAL TEAR EXTENDING THE ENTIRE LENGTH OF THE BALLOON. ALSO STATED THAT THE CATHETER WAS IN PLACE FOR APPROXIMATELY 10 HOURS AND THE CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802148 ↗
• MalfunctionApr 22, 2020Fracture; Crack; Fracture; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A CRACK AT THE Y CONNECTOR WHICH CAUSED THE CATHETER TO LEAK. THE CATHETER WAS REPORTEDLY REPLACED.

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

  MAUDE report 9985449 ↗
• MalfunctionMar 19, 2020Partial Blockage; Complete Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEYS WERE BLOCKED AND DID NOT DRAIN OR FLUSH.

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

  MAUDE report 9856696 ↗
• MalfunctionFeb 25, 2020Difficult to Insert; Leak/Splash; Material Puncture/Hole; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2019 A NURSE EXPERIENCED RESISTANCE WHILE INSERTING WATER INTO THE FOLEY BALLOON. UPON REMOVAL OF THE FOLEY CATHETER, A PINHOLE WAS NOTED IN THE BALLOON. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9750567 ↗
• MalfunctionFeb 14, 2020Deflation Problem; Material Puncture/Hole; Physical Resistance/Sticking; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A FOLEY ISSUE REPORTED AT MUSC ON (B)(6) 2019 BY THE 8D CHILDRENS FLOOR. THE 8 FR. FOLEY WITH LOT # NGCZ2377. THE RN WAS MET WITH RESISTANCE WHILE INSERTING WATER INTO THE BALLOON. UPON REMOVAL A PINHOLE WAS FOUND IN THE BALLOON. THERE WAS NO PATIENT HARM REPORTED. PER FOLLOW UP WITH THE SALES REP ON 6FEB2020, HE CONFIRMED THAT WHEN HE FOLLOWED UP IN PERSON HE WAS MADE AWARE OF THIS EVENT ON (B)(6)2020.

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

  MAUDE report 9714179 ↗
• MalfunctionFeb 14, 2020Material Puncture/Hole; Failure to Infuse; Physical Resistance/Sticking; Failure to Infuse

  IT WAS REPORTED THAT THERE WAS A FOLEY ISSUE REPORTED AT (B)(6) ON 08DEC2019 BY THEIR 8D CHILDRENS FLOOR. THE 8 FR. FOLEY WITH LOT # NGCZ2377. THE RN WAS MET WITH RESISTANCE WHILE INSERTING WATER INTO THE BALLOON. UPON REMOVAL A PINHOLE WAS FOUND IN THE BALLOON. THERE WAS NO PATIENT HARM REPORTED. PER FOLLOW UP WITH THE SALES REP ON 6FEB2020, HE CONFIRMED THAT WHEN HE FOLLOWED UP IN PERSON HE WAS MADE AWARE OF THIS EVENT ON 24JAN2020.

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

  MAUDE report 9714146 ↗
• MalfunctionJan 27, 2020Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO DEFLATE, AS ONLY 3 ML OF WATER CAME OUT DURING ASPIRATION. PER THE USER, THE CATHETER BALLOON WAS VISIBLY STILL INFLATED, SO THE INFLATION LUMEN WAS CUT AND THE CATHETER WAS THEN REMOVED.

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

  MAUDE report 9633187 ↗
• MalfunctionOct 17, 2019Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER PREMATURELY DEFLATED AND CAME OUT. AN 8 FRENCH FOLEY CATHETER WAS INSERTED USING STERILE TECHNIQUE. THE BALLOON PORT WAS VERIFIED, AND 5 ML OF FLUID WAS INJECTED INTO THE BALLOON PORT. IT WAS NOTED THERE WAS NO RESISTANCE AND URINE FLOW IN THE DRAIN BAG. THE FOLEY CAME ALL THE WAY OUT WITH A DEFLATED BALLOON AND THE STERILE WAS WATER COMING OUT OF THE BALLOON. THE FOLEY CATHETER AND THE STERILE FIELD WERE TAKEN DOWN AND THROWN OUT. A NEW FOLEY WAS PLACED WITH NO COMPLICATIONS.

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

  MAUDE report 9203199 ↗