Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 383 adverse event reports that list this exact device (DI 00801741025228), received between Aug 16, 2017 and Sep 29, 2026 — classified as 1 death, 22 injuries, 360 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (94 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 383 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935977 ↗
• MalfunctionSep 2, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566378 ↗
• MalfunctionSep 2, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562019 ↗
• MalfunctionJul 9, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING USE, MESSAGE FROM THE UROLOGY OUTPATIENT DEPARTMENT THAT LEAKAGE FROM THE FOLEY CATHETER RETENTION BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763748 ↗
• MalfunctionJun 19, 2026Inflation Problem

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT THE FOLEY CATHETER HAD DIFFICULTY INJECTING FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566047 ↗
• MalfunctionMay 21, 2026Calcified

  IT WAS REPORTED THAT URINE LEAKAGE ONTO THE PATIENT¿S PANTS WAS NOTICED. THE NURSE ATTEMPTED TO INFLATE THE BALLOON AFTER REMOVAL FROM THE PATIENT, AND A HOLE WAS OBSERVED IN THE BALLOON. A NEW FOLEY CATHETER WAS INSERTED. NO BLOOD WAS PRESENT IN THE URINE, AND CLEAR YELLOW URINE WAS RETURNED. PSR-3005762. THE LAST FOLEY CATHETER INSERTION OCCURRED ON (B)(6) 2026. SOME CRYSTALLIZATION WAS NOTED ON THE TIP OF THE CATHETER. NO TUGGING OR PULLING WAS OBSERVED, AND NO TRAUMA WAS IDENTIFIED DURING ASSESSMENT. NO SKIN BREAKDOWN WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250176 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole

  IT WAS REPORTED THAT URINE LEAKAGE ONTO THE PATIENT¿S PANTS WAS NOTICED. THE NURSE ATTEMPTED TO INFLATE THE BALLOON AFTER REMOVAL FROM THE PATIENT, AND A HOLE WAS OBSERVED IN THE BALLOON. A NEW FOLEY CATHETER WAS INSERTED. NO BLOOD WAS PRESENT IN THE URINE, AND CLEAR YELLOW URINE WAS RETURNED. PSR-3005762. THE LAST FOLEY CATHETER INSERTION OCCURRED ON (B)(6) 2026. SOME CRYSTALLIZATION WAS NOTED ON THE TIP OF THE CATHETER. NO TUGGING OR PULLING WAS OBSERVED, AND NO TRAUMA WAS IDENTIFIED DURING ASSESSMENT. NO SKIN BREAKDOWN WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143322 ↗
• MalfunctionMay 11, 2026Inflation Problem

  IT WAS REPORTED THAT MULTIPLE COVENANT FACILITIES HAVE REPORTED ISSUES WITH FOLEY CATHETER TRAYS, INCLUDING A NON-INFLATING BALLOON ON REF (B)(4) AND REPEATED INSTANCES OF FOLEY DRAINAGE BAGS DISCONNECTING FROM THE CATHETER WHILE THE RED SEAL REMAINED INTACT, SUGGESTING A POTENTIAL ADHESION ISSUE. THE MOST RECENT OCCURRENCE WAS IN THE CORONARY CARE UNIT USING A URINE METER TRAY, REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143321 ↗
• InjuryMay 3, 2026Material Rupture

  IT WAS REPORTED THAT FIRST FOLEY CATHETER APPROXIMATELY 5 MINUTES AFTER INSERTION, THE BALLOON DISLODGED; UPON INSPECTION, THE BALLOON WAS FOUND TO BE RUPTURED. SECOND FOLEY CATHETER A SECOND DEVICE WAS INSERTED IMMEDIATELY AFTER THE FIRST ONE RUPTURED; HOWEVER, WHILE PERFORMING AN ULTRASOUND EXAMINATION, A "POPPING" SOUND WAS HEARD. UPON INSPECTION, THE CATHETER HAD DISLODGED, AND THE BALLOON WAS FOUND TO BE RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062912 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKING; HOWEVER, THE SOURCE AND LOCATION OF THE LEAK WERE UNCLEAR, AND FEEDBACK FROM THE SUPPLY CHAIN CONTACT WAS PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045495 ↗
• MalfunctionApr 17, 2026Disconnection

  IT WAS REPORTED THAT IMMEDIATELY AFTER PLACEMENT THE FOLEY CATHETER WATER COULD NOT BE INJECTED EVEN AFTER INSERTING THE SYRINGE, AND THEN THE VALVE CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918008 ↗
• MalfunctionApr 10, 2026Inflation Problem

  IT WAS REPORTED BY THE NURSE STATED THAT FOLEY CATHETER BALLOON WOULD NOT INFLATE WHILE THE CATHETER WAS IN THE PATIENT BUT ONCE TAKEN OUT OF PATIENT IT WOULD THEN INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845758 ↗
• MalfunctionMar 13, 2026Material Rupture

  IT WAS REPORTED THAT CUSTOMER STATED, THREE SEPARATE CATHETERS EXPERIENCED BALLOON RUPTURES POST-INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591854 ↗
• MalfunctionMar 12, 2026Material Rupture

  IT WAS REPORTED THAT CUSTOMER STATED, THREE SEPARATE CATHETERS EXPERIENCED BALLOON RUPTURES POST-INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24585000 ↗
• MalfunctionMar 12, 2026Material Rupture

  IT WAS REPORTED THAT THE THREE SEPARATE CATHETERS EXPERIENCED BALLOON RUPTURES POST-INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584754 ↗
• MalfunctionMar 11, 2026Inaccurate Flow Rate

  IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT REQUIRED FOLEY CATHETERIZATION. A FOLEY CATHETER WAS INSERTED INTO THE URETHRA USING PROPER TECHNIQUE; HOWEVER, NO URINE RETURN WAS NOTED. WHEN A SECOND FOLEY CATHETER WAS PLACED BY THE SAME PROVIDER INTO THE SAME ORIFICE USING THE SAME TECHNIQUE, URINE RETURN WAS NOTED IMMEDIATELY. THERE WERE NO CHANGES OR DIFFERENCES IN EITHER PROCEDURE OTHER THAN THE EQUIPMENT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570329 ↗
• MalfunctionFeb 24, 2026Material Puncture/Hole

  IT WAS REPORTED THAT AFTER USE IN THE OPERATION, THE FOLEY CATHETER SPONTANEOUS REMOVAL OF THE BALLOON WAS OBSERVED IN THE C2 WARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429713 ↗
• MalfunctionFeb 6, 2026Material Puncture/Hole

  IT WAS REPORTED BY THE CUSTOMER THAT THE REGISTERED NURSE HAD PLACED A FOLEY CATHETER WITH A BALLOON INFLATION OF 10 ML AND HAD SECURED IT WITH A SECUREMENT DEVICE. WHEN THE REGISTERED NURSE AND THE MEDICAL DOCTORS WERE AT THE BEDSIDE, THE FOLEY CATHETER WAS FOUND TO HAVE BEEN DISCONTINUED WITH THE BALLOON DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279264 ↗
• MalfunctionFeb 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER, WHICH HAD BEEN INSERTED AND MANAGED FOR URINARY CATHETERIZATION IN THE 11TH-FLOOR SOUTH WARD, WAS NATURALLY DISLODGED. THE BALLOON WAS DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278714 ↗
• MalfunctionFeb 6, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT A CATHETER WAS PLACED AND MANAGED FOR URINARY DRAINAGE IN THE 11TH FLOOR SOUTH WARD. FOLEY CATHETER SPONTANEOUSLY DISLODGED AND THE BALLOON PORTION WAS DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278699 ↗
• MalfunctionFeb 5, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE REGISTERED NURSE PLACED FOLEY CATHETER WITH BALLOON INFLATION OF 10ML AND SECURED WITH SECUREMENT DEVICE. WHEN REGISTERED NURSE AND MDS WERE AT BEDSIDE, FOLEY CATHETER FOUND DISCONTINUED WITH BALLOON DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268754 ↗
• MalfunctionJan 28, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD TWO DIFFERENT FOLEY BALLOONS RUPTURE AND LEAK. THEY FILED A SEPARATE PIR ON FIRST BALLOON FAIL WHICH WAS A TEMP SENSING FOLEY. THE SECOND INCIDENT WAS A SILICONE FOLEY. SINCE TWO BALLOONS RUPTURED, THE PATIENT HAD THREE FOLEY INSERTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206424 ↗
• InjuryDec 19, 2025Material Invagination; Material Twisted/Bent; Material Invagination; Material Twisted/Bent

  IT WAS REPORTED THAT ON THE (B)(6) 2025, ATTEMPTED RETENTION OF THE FOLEY CATHETER AND ON THE (B)(6) 2025, WHEN TRYING TO REMOVE, THERE WAS A SENSE OF DISCOMFORT, AND IT COULD NOT BE REMOVED. ULTIMATELY, WE REQUESTED THE UROLOGIST TO REMOVE IT, AND IT WAS SUCCESSFULLY REMOVED. ACCORDING TO THE UROLOGIST, IT MAY HAVE CAUGHT ON THE FOLD NEAR THE CUFF. PLEASE INVESTIGATE WHETHER THERE WAS ANY DEFECT IN THE PRODUCT. IF THERE ARE NO PRODUCT ABNORMALITIES, THERE WAS A POSSIBILITY OF CAFROL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information

  MAUDE report 23857706 ↗
• MalfunctionDec 4, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT TIP OF THE FOLEY CATHETER WAS DETACHED. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON (B)(6) 2025, STATED THAT, WHEN OPENED THE STERILIZATION PACK, THE TIP OF THE CATHETER WAS BENT AND NEATLY BENT AS IT HAS A HABIT OF FOLDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723076 ↗
• MalfunctionNov 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT IN OR DEPARTMENT, INSERTED ONE OF THESE FOLEY CATHETERS IN A PATIENT AND COULD NOT GET THE BALLOON TO INFLATE. THEY OPENED A 2ND TRAY AND HAD THE SAME ISSUE WITH THAT TRAY. THEY DID NOT KEEP ANY OF THE USED CATHETERS. THEY ONLY HAVE THE OUTER PACKAGES, BUT THEY DO NOT HAVE THE LOT NUMBERS ON THE OUTER PACKAGING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 17NOV2025, IT WAS REPORTED THAT THEY HAVE THE OUTER WRAPPERS FOR THE 2 FOLEY TRAYS, BUT UNFORTUNATELY THE STAFF DID NOT RETAIN THE DEFECTIVE CATHETERS. LOT NUMBER WAS NOT AVAILABLE. TWO URINARY CATHETER INSERTIONS WERE REQUIRED. REMOVAL AND REINSERTION OF URINARY CATHETER WERE PERFORMED. THEY WERE PERFORMED TROUBLESHOOTING. ATTEMPTED TO INSERT A FOLEY AND THE BALLOON WOULD NOT INFLATE. FOLEY REMOVED. OPENED ANOTHER FOLEY KIT AND WHILE TESTING THE BALLOON A LEAK WAS SEEN, AND THIS BALLOON WOULD ALSO NOT INFLATE. OPENED ANOTHER FOLEY KIT, BALLOON TESTED AND INFLATED APPROPRIATELY. FOLEY INSERTED AND THEN UNABLE TO DRAW URINE FROM THE PORT WITH SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639922 ↗