Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI24Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741025266), received between Jun 19, 2018 and Apr 4, 2022 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT WATER HAD TO BE POURED INTO THE FOLEY CATHETER IN ORDER FOR IT TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995299 ↗
• MalfunctionMar 15, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE BULB OF THE FOLEY CATHETER KEPT DEFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770519 ↗
• MalfunctionApr 2, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE WHEN IT WAS IN THE PATIENT AND DID NOT HAVE IT ANY LONGER. PER FOLLOW UP ON 09APR2021 IT WAS STATED THAT THE CATHETER WAS NOT INSERTED IN THE PATIENT WHEN THE DEFECT WAS NOTICED. THE CUSTOMER NOTED THE ISSUE DURING THE PRETEST THE BALLOON WOULD INFLATE BUT DID NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610148 ↗
• MalfunctionJul 29, 2020Product Quality Problem; Material Separation; Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CATHETER WAS NOT OF GOOD QUALITY AND THE PATIENT STATED THAT THERE WERE ISSUES WITH THEM PINCHING AND THEY WERE MORE FLIMSY. THE PATIENT ALSO STATED THAT THE CATHETER FELL APART DURING INSERTION.

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

  MAUDE report 10341029 ↗
• MalfunctionJul 23, 2020Break; Difficult to Insert

  IT WAS REPORTED THAT THE CATHETER WAS NOT OF GOOD QUALITY AND THE PATIENT STATED THAT THERE WERE ISSUES WITH THEM PINCHING AND THEY WERE MORE FLIMSY. THE PATIENT ALSO STATED THAT THE CATHETER FELL APART DURING INSERTION. PER ADDITIONAL INFORMATION, THE CUSTOMER NOTED THAT WHEN THE SUPRAPUBIC CATHETER BUCKLED DURING INSERTION AND SEEMED TO KINK, RESTRICTING THE FLOW THROUGH THE CATHETER SINCE IT WAS MORE PLIABLE TOWARDS THE END WHERE IT ENTERS THE BODY. THE CUSTOMER NOTED THAT WHEN THIS OCCURRED, THE PATIENT EXPERIENCED LEAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10316995 ↗
• MalfunctionJul 1, 2020Inaccurate Flow Rate; Inaccurate Flow Rate; Obstruction of Flow

  IT WAS REPORTED THAT THE QUALITY OF THE CATHETER WAS NOT HOLDING UP AND NOT ALLOWING THE URINE TO FLOW THROUGH.

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

  MAUDE report 10217400 ↗
• MalfunctionJun 30, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE QUALITY OF THE CATHETERS WERE NOT HOLDING UP RESULTED IN LEAKS. COMPLAINANT ALSO STATED THAT THE CATHETERS WOULD NOT ALLOWED URINE TO FLOW THROUGH.

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

  MAUDE report 10215047 ↗
• MalfunctionDec 6, 2019Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT STATED THE CATHETER DID NOT SEEM TO BE WORKING, BECAUSE URINE WAS COMING OUT THROUGH BOTH THE CATHETER AND THE URETHRA. THE PATIENT WENT THROUGH MORE CATHETERS THAN USUAL BECAUSE OF THE PROBLEM.

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

  MAUDE report 9433796 ↗
• MalfunctionJul 22, 2019Deflation Problem; Deflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE CATHETER WOULD NOT HOLD SALINE AND LEAKED UPON INFLATION.

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

  MAUDE report 8813392 ↗
• InjuryJun 19, 2018Partial Blockage; Sediment, Precipitate Or Deposit In Device Or Device Ingredient

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS BLOCKED WITH SEDIMENT; AND THE PATIENT COULD NOT PASS URINE. ALLEGEDLY THE PATIENT EXPERIENCED PAIN AND DEVELOPED A URINARY TRACT INFECTION, AND WAS TREATED WITH LEVAQUIN ANTIBIOTICS. THE COMPLAINANT NOTED THAT THE PATIENT'S DAUGHTER FLUSHED THE FOLEY CATHETER DAILY AND NOTICED BLOOD IN THE PATIENT'S URINE.

  Patient problems: Hematuria; Pain; Urinary Tract Infection

  MAUDE report 7616387 ↗