Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI14Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741025334), received between Nov 30, 2018 and Oct 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON DEFLATED ON TWO OF THE FOLEYS. PATIENT HAD TO CHANGE PREMATURELY TWICE. DEFECT IN THE FOLEY BALLOON. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353589 ↗
• MalfunctionJul 9, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT AUTH STATED THAT THE FOLEY CATHETERS BALLOON HAS BEEN DEFLATING PREMATURELY, AND THERE IS ALSO LEAKING. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457435 ↗
• MalfunctionMay 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT HOLDING THE INSTILLATION OF THE STERILE WATER. THE FOLEYS INADVERTENTLY CAME OUT OF THE PATIENT. THAT HAPPEN AT POST ANESTHESIA CARE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960960 ↗
• MalfunctionApr 30, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT HOLDING THE INSTILLATION OF THE STERILE WATER. THE FOLEYS INADVERTENTLY CAME OUT OF THE PATIENT SHORTLY AFTER INSERTING THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935760 ↗
• MalfunctionApr 30, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS NOT HOLDING THE INSTILLATION OF THE STERILE WATER. THE FOLEYS INADVERTENTLY CAME OUT OF THE PATIENT AFTER IT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935032 ↗
• MalfunctionJun 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SILICONE COUDE FOLEY CATHETER WAS LEAKING, BALLOON WAS PREMATURELY DEFLATED AND SLIPPED OUT. FOLEY CATHETER HAD TO BE REMOVED AND NEW CATHETER WAS INSERTED. PER FOLLOW UP RESPONSE VIA EMAIL ON 05JUN2024, NO IMPACT TO THE PATIENT DUE TO THIS DEVICE AND NEW CATHETER WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566240 ↗
• MalfunctionMar 5, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THEY HAD 3 BALLOONS OF FOLEY CATHETER BURST INSIDE OF THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER FOLLOW UP ON (B)(6) 2024, THEY STATED THAT THE CATHETER MAKES IT A COUPLE OF WEEKS BEFORE FAILING. AT THIS TIME THERE WAS NO MISSING BALLOON PIECES, BUT TESTING WAS STILL ON GOING TO FIND THE CAUSE AND MAKE SURE THERE WAS NO PIECES LEFT INSIDE. PATIENT EXPERIENCED EXTREME PAIN AND MENTAL STRESS DUE TO THE USAGE OF DEVICE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Distress; Pain

  MAUDE report 18836984 ↗
• MalfunctionFeb 29, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THEY HAD 3 BALLOONS OF FOLEY CATHETER BURST INSIDE OF THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER FOLLOW UP ON 15FEB2024, THEY STATED THAT THE CATHETER MAKES IT A COUPLE OF WEEKS BEFORE FAILING. AT THIS TIME THERE WAS NO MISSING BALLOON PIECES, BUT TESTING WAS STILL ON GOING TO FIND THE CAUSE AND MAKE SURE THERE WAS NO PIECES LEFT INSIDE. PATIENT EXPERIENCED EXTREME PAIN AND MENTAL STRESS DUE TO THE USAGE OF DEVICE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Distress; Pain

  MAUDE report 18807218 ↗
• MalfunctionJun 3, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS APPROXIMATELY 10ML ONTO PLASTIC-LINED PAPER ON PATIENT'S LAP AND THE INFUSION STOPPED. FOLEY CATHETER WAS ASSESSED AND COULD VISIBLE SEE HOLE IN CATHETER. STATED THAT THE PATIENT HAD BEEN INFORMED, RECATHED AND DOSE APPLIED TO BLADDER AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594708 ↗
• MalfunctionMay 24, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF TWO SEPARATE CATHETERS BURST AND FELL OUT OF THE PATIENT. IT WAS STATED THAT THE SECOND ATTEMPT TO INSERT THE CATHETER LED TO TRY A COUDE TIP FOLEY CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871959 ↗
• MalfunctionMay 16, 2019Leak/Splash

  IT WAS REPORTED THAT THE PATIENT LEAKED AROUND THE MEATUS WHILE USING THE LUBRISIL 2-WAY CATHETER.

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

  MAUDE report 8615640 ↗
• MalfunctionNov 30, 2018Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE COUDE FOLEY CATHETER LEAKED FROM AN UNKNOWN LOCATION.

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

  MAUDE report 8118800 ↗