Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI20Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741025242), received between May 2, 2019 and Jul 15, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25826318 ↗
• MalfunctionJun 27, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED THE FOLEY CATHETER HAD PIN HOLES AND WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25646123 ↗
• MalfunctionDec 24, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT PATIENT WENT TO THE DOCTOR TO HAVE THE CATHETER CHANGED AND WHEN DOCTOR REMOVED THE CATHETER IT WAS DAMAGED, SO THE DOCTOR HAD TO REPLACE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890472 ↗
• MalfunctionSep 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER HAD STERILE WATER LEAKAGE FROM UNKNOWN LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133149 ↗
• MalfunctionSep 22, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE, THEY DISCOVERED A STERILE WATER LEAK NEAR THE FUNNEL OF THE FOLEY CATHETER. LEAK NEAR THE FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110345 ↗
• MalfunctionJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTER THAT THE PATIENT SAID THAT THE CATHETER CAME OUT, BUT HE DID SAY IF THE NURSE GOT FLUID FROM THE 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 22668539 ↗
• MalfunctionJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLEY CATHETER WAS INSERTED FOR URINARY CATHETERIZATION IN WARD 6 WEST AND WAS BEING MANAGED, BUT IT WAS NATURALLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359399 ↗
• MalfunctionMar 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BULB FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503983 ↗
• MalfunctionMay 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEFT IN PLACE DURING THE SURGERY AND WAS REMOVED NATURALLY WITHIN AN HOUR AFTER BEING LEFT IN PLACE. THERE WAS A LEAKAGE IN A BALLOON PART. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 01MAY2024, IT WAS CONFIRMED THAT NOT SURE ABOUT THE BALLOON BURST. IT WAS STATED THAT THERE ARE NONE LEFT IN PATIENT BODY. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309799 ↗
• MalfunctionDec 29, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN FOLEY CATHETER BALLOON. (BATCH NUMBER [NGGT5274]); (BATCH NUMBER [NGHU3339]); (BATCH NUMBER [NGHP1134]).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418231 ↗
• MalfunctionDec 27, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN FOLEY CATHETER BALLOON. (BATCH NUMBER NGGT5274, NGHU3339 AND NGHP1134).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400459 ↗
• MalfunctionDec 15, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN FOLEY CATHETER BALLOON. (BATCH NUMBER [NGGT5274]); (BATCH NUMBER [NGHU3339]); (BATCH NUMBER [NGHP1134]).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334959 ↗
• MalfunctionJul 27, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS BECOMING HARDER TO COME OUT. CUSTOMER STATED IT SWELLED UP ON THE END AND TORE THEM UP WHEN PULLED IT OUT. CUSTOMER STATED THAT THEY ALWAYS HAD BLEEDING WHEN THEY REMOVED THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 15111673 ↗
• MalfunctionMar 17, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF THE PATIENT DUE TO BALLOON RUPTURE AFTER 12 HOURS OF PLACEMENT. IT WAS MENTIONED THAT WATER LEAKED FROM THE BALLOON. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 25FEB2022, A PINHOLE WAS DISCOVERED IN THE RETURNED SAMPLE, BUT NO BALLOON BURST WAS DISCOVERED. IT WAS ALSO CONFIRMED THAT THE WATER LEAKED FROM A PINHOLE. ADDITIONALLY CONFIRMED THAT DEVICE USED ON THE PATIENT AND THE CATALOG NUMBER WAS 7760020LR, NOT 7760014LR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802329 ↗
• MalfunctionAug 8, 2019Deflation Problem; Fluid/Blood Leak; Device Fell; Deflation Problem

  IT WAS REPORTED THAT SEVEN CATHETERS KEPT FALLING OUT OF THE PATIENT RESULTING IN A URINE LEAK. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8876191 ↗
• MalfunctionAug 7, 2019Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT DEFLATE WHEN THE PATIENT WENT TO HAVE IT CHANGED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8870686 ↗
• MalfunctionJun 20, 2019Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST WHILE THE CUSTOMER WAS DRIVING.

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

  MAUDE report 8716835 ↗
• MalfunctionMay 2, 2019Deflation Problem; Material Invagination; Retraction Problem; Material Invagination

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER "PANCAKES FLAT" AFTER DEFLATING MAKING IT DIFFICULT AND PAINFUL TO REMOVE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8575567 ↗