Bardex® Lubri-Sil® All-Silicone Foley Catheter 175818Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741034176), received between Jun 6, 2017 and Jul 10, 2026 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787494 ↗
• MalfunctionMar 13, 2026Material Puncture/Hole

  IT WAS REPORTED BY THE CUSTOMER THAT ARD INDWELLING FOLEY CATHETERS FROM LOT NGKP1715 PRESENTED A SUSPECTED CATHETER INTEGRITY DEFECT THAT AFFECTED PRODUCT PERFORMANCE AND PATIENT SAFETY. THE ISSUE OCCURRED WITH THREE (3) FOLEY CATHETERS FROM THE SAME LOT THAT WERE INSERTED ON (B)(6) 2026, (B)(6) 2026, AND (B)(6) 2026, ALL OF WHICH RESULTED IN UNEXPECTED BALLOON DEFLATION AFTER INSERTION. PRIOR TO INSERTION, NURSING STAFF HAD PERFORMED A BALLOON INTEGRITY CHECK AND CONFIRMED THAT THE RETENTION BALLOON WAS INTACT AND ABLE TO RETAIN WATER. HOWEVER, UPON FOLLOW UP ASSESSMENT AFTER BALLOON FAILURE, A SMALL HOLE WAS IDENTIFIED IN THE CATHETER, SUGGESTING A POTENTIAL DEFECT THAT HAD NOT BEEN DETECTAB;E DURING PREINSERTIONBALLOON TEST. THIS DEFECT REQUIRED REPEATED CATHETER REPLACEMENT AND REINSERTION, INCREASING PATIENT DISCOMFORT AND THE RISK OF COMPLICATIONS. NO MEDICAL INTERVENTION REPORTED. REFERENCE: MW5183115, MW5183116.

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

  MAUDE report 24595870 ↗
• MalfunctionMar 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT ARD MEDICAL INDWELLING FOLEY CATHETERS FROM LOT NGKP1715 HAD PRESENTED A SUSPECTED CATHETER INTEGRITY DEFECT THAT HAD AFFECTED PRODUCT PERFORMANCE AND PATIENT SAFETY. THE ISSUE HAD OCCURRED WITH THREE (3) FOLEY CATHETERS FROM THE SAME LOT THAT HAD BEEN INSERTED ON (B)(6) 2026, (B)(6) 2026, AND (B)(6) 2026, ALL OF WHICH HAD RESULTED IN UNEXPECTED BALLOON DEFLATION AFTER INSERTION. PRIOR TO INSERTION, NURSING STAFF HAD PERFORMED A BALLOON INTEGRITY CHECK AND HAD CONFIRMED THAT THE RETENTION BALLOON WAS INTACT AND ABLE TO RETAIN WATER. HOWEVER, UPON FOLLOW UP ASSESSMENT AFTER THE BALLOON FAILURES, A SMALL HOLE HAD BEEN IDENTIFIED IN THE CATHETER, SUGGESTING A POTENTIAL DEFECT THAT HAD NOT BEEN DETECTABLE DURING THE PRE INSERTION BALLOON TEST. THIS DEFECT HAD REQUIRED REPEATED CATHETER REPLACEMENT AND REINSERTION, INCREASING PATIENT DISCOMFORT AND THE RISK OF COMPLICATIONS. NO MEDICAL INTERVENTION WAS REPORTED. REFERENCE: (B)(4), (B)(4), AND (B)(4).

  Patient problems: Discomfort

  MAUDE report 24511906 ↗
• MalfunctionMar 4, 2026Material Puncture/Hole

  IT WAS REPORTED THAT INDWELLING FOLEY CATHETERS FROM LOT NGKP1715 HAD PRESENTED A SUSPECTED CATHETER INTEGRITY DEFECT THAT HAD AFFECTED PRODUCT PERFORMANCE AND PATIENT SAFETY. THE ISSUE HAD OCCURRED WITH THREE (3) FOLEY CATHETERS FROM THE SAME LOT THAT HAD BEEN INSERTED ON (B)(6) 2026, (B)(6) 2026, AND (B)(6) 2026, ALL OF WHICH HAD RESULTED IN UNEXPECTED BALLOON DEFLATION AFTER INSERTION. PRIOR TO INSERTION, NURSING STAFF HAD PERFORMED A BALLOON INTEGRITY CHECK AND HAD CONFIRMED THAT THE RETENTION BALLOON WAS INTACT AND ABLE TO RETAIN WATER. HOWEVER, UPON FOLLOW UP ASSESSMENT AFTER THE BALLOON FAILURES, A SMALL HOLE HAD BEEN IDENTIFIED IN THE CATHETER, SUGGESTING A POTENTIAL DEFECT THAT HAD NOT BEEN DETECTABLE DURING THE PRE INSERTION BALLOON TEST. THIS DEFECT HAD REQUIRED REPEATED CATHETER REPLACEMENT AND REINSERTION, INCREASING PATIENT DISCOMFORT AND THE RISK OF COMPLICATIONS. NO MEDICAL INTERVENTION WAS REPORTED. REFERENCE: MW5183114, MW5183115 AND MW5183116.

  Patient problems: Discomfort

  MAUDE report 24508168 ↗
• MalfunctionFeb 26, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A TWO-NURSE INSERTION OF A FOLEY CATHETER 18FR, THE NURSE NOTED THE SYRINGE TO BE FILLED TO ONLY 9ML VS THE 10 ML THAT THE PACKAGE STATES IT SHOULD BE INFLATED CATHETER 10 ML WITH STERILE WATER. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 30MAR2026, IT WAS REPORTED THAT THE PRODUCT IS NO LONGER AVAILABLE UNFORTUNATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464323 ↗
• MalfunctionFeb 3, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DISINFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254569 ↗
• MalfunctionDec 17, 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). LABELING DISCREPANCIES: 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. THE BALLOON FILL AMOUNTS DO NOT MATCH ON THE 20FR AND 12FR PRODUCTS/PACKAGING: FOLEY CATHETER SIZE 20FR. FOLEY CATHETER SIZE 12FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830502 ↗
• MalfunctionJun 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE TRAINING CONDUCTED ON (B)(6) 2025, AT 23:58, IN WHICH THE PROPER USE OF THE LUBRISIL TRAY FOR BLADDER CATHETER WAS EXPLAINED, AN EQUIPMENT FAILURE OCCURRED. AT THE TIME OF INSUFFLATING THE FOLEY CATHETER BALLOON, THE SECOND LINE OF THE DEVICE RUPTURED. THAT RUPTURE CAUSED THE INJECTABLE SOLUTION USED TO INFLATE THE BALLOON TO SPILL COMPLETELY, SINCE THE SYRINGE INLET WAS COMPLETELY DETACHED. THE DEMONSTRATION WAS STOPPED IMMEDIATELY, AND THE INCIDENT WAS DOCUMENTED FOR ANALYSIS. PRODUCT DATA WAS RETAINED FOR TRACEABILITY. THAT INCIDENT OCCURRED DURING A TRAINING ACTIVITY, WITHOUT INVOLVING A PATIENT. HOWEVER, IT IS CONSIDERED IMPORTANT TO REPORT DUE TO THE PROXIMITY OF THE BATCH EXPIRATION DATE AND THE POSSIBLE IMPLICATION OF A MANUFACTURING DEFECT. THERE WAS NO DIRECT IMPACT ON ANY PATIENT AS THE INCIDENT OCCURRED DURING TECHNICAL TRAINING AND NOT IN AN ACTUAL CLINICAL SETTING. NO INVASIVE PROCEDURES WERE PERFORMED ON PEOPLE. THE INCIDENT CAUSED A DISRUPTION IN THE TRAINING, WHICH AFFECTED THE CONTINUITY OF LEARNING AND PRACTICAL DEMONSTRATION. THE HEALTH PROFESSIONAL IN CHARGE OF THE TRAINING HAD TO TEMPORARILY SUSPEND THE SESSION TO EVALUATE THE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236635 ↗
• MalfunctionFeb 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOTED TO BE LEAKING AND SPONTANEOUSLY CAME OUT ON ITS OWN. IT WAS NOTED AFTER LOOKING AT THE CATHETER TIP THE BALLOON HAD RUPTURED. CHRONIC CARE MANAGEMENT WAS MADE AWARE AND VISUALIZED THE CATHETER TIP. INSTRUCTED TO CALL UROLOGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410386 ↗
• MalfunctionJul 6, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD FELL OUT. CUSTOMER REPORTED THAT THE THREE DIFFERENT PATIENTS HAD THEIR LUBRISIL FOLEY CATHETERS FALL OUT DESPITE BEING SECURED BY STATLOCKS AND THE CATHETER BALLOONS BEING FILLED. IT WAS STATED THAT TWO OF THE PATIENTS HAD NEW LUBRISIL CATHETERS FITTED, BUT THESE ALSO FELL OUT. THE CUSTOMER WAS UNSURE WHAT MAY HAVE CAUSED THESE ISSUES, BUT THE USER WORKS ON WARD 3, AND THEY HAVE IDENTIFIED THAT THE MAJORITY OF THE STAFF WERE POSITIONING THE STATLOCK INCORRECTLY AND THEREFORE LEAVING TOO MUCH SLACK. IT WAS ALSO STATED THAT THEY HAVE NOW PROVIDED TRAINING ON THIS. AS FAR AS I KNOW, NO OTHER AREAS IN THE HOSPITAL WERE EXPERIENCING THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276252 ↗
• InjuryJul 5, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CUSTOMER REPORTED THAT 5 PATIENTS HAD EXPERIENCED URINARY RETENTION DESPITE CATHETERIZATION. THE WORST AFFECTED PATIENT HAD MORE THAN 500ML OF URINE RETAINED AS PER THE BLADDER SCAN WHICH WAS PERFORMED. THE CUSTOMER WAS UNSURE WHAT WAS THE CAUSE FOR THE RETENTION BUT THE USER OBSERVED THAT THE STAFF HAD BEEN SECURING THE CATHETERS INCORRECTLY WITH STATLOCK AND THEREFORE LEAVING TOO MUCH SLACK.

  Patient problems: Urinary Retention

  MAUDE report 17254827 ↗
• MalfunctionAug 9, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETERS HAD TO BE REPLACED BECAUSE THE BALLOONS HAD A HOLE IN THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191273 ↗
• MalfunctionMay 16, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT CATHETER BLOCKAGE AND ACCIDENTAL REMOVAL WHEN ASKED OF COMPLICATIONS WHILE USING THE LUBRISIL HYDROGEL COATED ALL SILICONE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407517 ↗
• MalfunctionMay 13, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT SYMPTOMATIC URINARY TRACT INFECTION, HEMATURIA, CATHETER BLOCKAGE AND ACCIDENTAL REMOVAL WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE LUBRISIL HYDROGEL COATED SILICONE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401104 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT SYMPTOMATIC URINARY TRACT INFECTION, HEMATURIA, CATHETER BLOCKAGE AND ACCIDENTAL REMOVAL WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE LUBRISIL HYDROGEL COATED SILICONE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR SYMPTOMATIC URINARY TRACT INFECTION AND HEMATURIA.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 14355361 ↗
• MalfunctionNov 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING AROUND THE OUTSIDE AND NEEDED A 20F.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771767 ↗
• MalfunctionJun 19, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING AROUND THE MEATUS. IT WAS NOTED THAT THE PATIENT HAS BEEN REQUESTED FOR 20FR.

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

  MAUDE report 10174493 ↗
• MalfunctionJun 4, 2020Decrease in Pressure; Decrease in Pressure; Device Fell

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT.

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

  MAUDE report 10121283 ↗
• InjuryFeb 26, 2020Fluid/Blood Leak; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A NEW FOLEY WAS REINSERTED ON (B)(6) 2020 RESULTED IN A CAUTI. IN ADDITION, A DRAIN BAG LEAKED. THE PRODUCT CATALOG NUMBER FOR THE BAG WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 9757099 ↗
• MalfunctionDec 13, 2019Incorrect Measurement; Complete Blockage; Incorrect Measurement

  IT WAS REPORTED THAT THE EYELETS ON THE FOLEY CATHETER WERE ABOUT 30% SMALLER THAN USUAL WHICH REPORTEDLY CAUSED THE CATHETER TO GET CLOGGED EASILY.

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

  MAUDE report 9465616 ↗
• MalfunctionJul 17, 2019Deflation Problem; Deflation Problem; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT SALINE LEAKED FROM MULTIPLE HOLES IN THE BALLOON.

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

  MAUDE report 8798734 ↗
• MalfunctionJan 2, 2019Deflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER DEFLATED PREMATURELY. THE PATIENT REPORTEDLY EXPERIENCED PAIN WITH THE REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT THEN RE-INFLATED THE BALLOON AND ALLEGEDLY OBSERVED THAT THE BALLOON WAS LARGER ON ONE SIDE THAN THE OTHER. THE COMPLAINANT NOTED THAT THE BALLOON WAS INFLATED WITH 10CC OF FLUID.

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

  MAUDE report 8209901 ↗
• MalfunctionJan 2, 2019Deflation Problem; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER DEFLATED PREMATURELY. THE PATIENT REPORTEDLY EXPERIENCED PAIN WITH THE REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT THEN RE-INFLATED THE BALLOON AND ALLEGEDLY OBSERVED THAT THE BALLOON WAS LARGER ON ONE SIDE THAN THE OTHER. THE COMPLAINANT NOTED THAT THE BALLOON WAS INFLATED WITH 10CC OF FLUID.

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

  MAUDE report 8209899 ↗
• MalfunctionSep 19, 2018Use of Device Problem; Material Integrity Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BALLOON "BUNCHED UP" RESULTING IN AN EXTRA RIBBING AROUND THE FOLEY CATHETER. THE COMPLAINANT REPORTEDLY TESTED THE BALLOON BY PULLING BACK THE SYRINGE TO REMOVE THE WATER FROM THE BALLOON. THE COMPLAINANT EXPERIENCED PAIN WITH REMOVAL OF THE CATHETER.

  Patient problems: Pain

  MAUDE report 7890358 ↗
• MalfunctionSep 10, 2018Deflation Problem; Inflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WAS NOT STAYING FULLY INFLATED. THE BALLOON STAYED INTACT AND THE CATHETER DID NOT FALL OUT OF THE PATIENT.

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

  MAUDE report 7861741 ↗