Bardex® Lubricath® Foley Catheter 0119L18Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741019067), received between Jul 6, 2022 and Sep 2, 2026 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562024 ↗
• MalfunctionJul 31, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100476 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT ONE DAY AFTER PLACEMENT THE FOLEY CATHETER HAD URINE LEAKAGE AND THE BALLOON WAS FOUND TO BE RUPTURED WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009906 ↗
• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT AFTER INSERTION, THE FOLEY CATHETER BALLOON RUPTURED AND WAS SPONTANEOUSLY EXPELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326368 ↗
• MalfunctionFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT INSERTION VIA OPERATION ROOM ON (B)(6) 2026. RUPTURE OF THE FOLEY CATHETER BALLOON WAS CONFIRMED IN THE WARD ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259546 ↗
• MalfunctionJan 9, 2026Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT WHEN USED IN UROLOGY, THE 3-WAY FOLEY CATHETER BALLOON DID NOT DRAIN. PER FOLLOW UP INFORMATION RECEIVED ON 30DEC2025, STATED THAT IT WAS UNKNOWN WHETHER CATHETER DID NOT DRAIN URINE OR STERILE WATER DID NOT DRAIN FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029846 ↗
• MalfunctionDec 11, 2025Failure to Infuse; Component Misassembled; Failure to Infuse

  It was reported that this was an incident of the Foley catheter that had difficulty in water injection, and the use was discontinued due to difficulty in water injection. Since it was a 3 way catheter, it was unclear whether the infusion was with fixed water or through the irrigation lumen.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778991 ↗
• MalfunctionOct 15, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT SHORTLY AFTER RETENTION OF THE FOLEY CATHETER, SPONTANEOUS DISLODGEMENT OCCURRED DUE TO RUPTURE OF THE BALLOON CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278686 ↗
• MalfunctionOct 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN IN USE THE FOLEY CATHETER BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210242 ↗
• MalfunctionSep 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO DAYS AFTER INSERTION OF THE FOLEY CATHETER, THE BALLOON WAS REMOVED NATURALLY AND FOUND TO BE RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183641 ↗
• MalfunctionSep 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PLACEMENT THERE WAS A LEAK FROM THE FOLEY CATHETER BALLOON CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23166549 ↗
• MalfunctionSep 10, 2025Material Fragmentation; Material Puncture/Hole; Material Fragmentation; Material Puncture/Hole

  IT WAS REPORTED THAT BEFORE USE, FOLEY CATHETER TIP WAS BROKEN. PER FOLLOW UP INFORMATION RECEIVED ON 09SEP2025, CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017423 ↗
• MalfunctionJul 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER WAS NATURALLY REMOVED AFTER PLACEMENT DUE TO A CRACK IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520444 ↗
• MalfunctionJul 14, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT BEFORE USE THE FOLEY CATHETER WHITE CAP OF THE IRRIGATION LUMEN WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494724 ↗
• MalfunctionMay 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THREE DAYS AFTER PLACEMENT THE FOLEY CATHETER BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053973 ↗
• MalfunctionMay 2, 2025Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE, THE RETURN LINE OF THE FOLEY CATHETER WAS CLOGGED AND COULD NOT BE CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949586 ↗
• MalfunctionApr 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THEY DISCOVERED A HOLE IN THE FOLEY CATHETER BALLOON WHEN ATTEMPTING TO INSERT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856812 ↗
• MalfunctionApr 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING PRE-TEST, THAT THE FOLEY CATHETER BALLOON INFLATES, BUT THERE WAS WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21815538 ↗
• MalfunctionNov 22, 2024Inflation Problem; Inability to Irrigate; Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT IN A 3-WAY CATHETER, EVEN WHEN A SYRINGE WAS INSERTED INTO THE IRRIGATION PORT, WATER COULD NOT BE INJECTED INTO THE FOLEY CATHETER, AND IT WAS SUGGESTED THAT IT MAY BE CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757040 ↗
• MalfunctionOct 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER WAS INSERTED DURING OPE ON SEPTEMBER 13TH. BALLOON RUPTURE CONFIRMED ON SEPTEMBER 14TH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370988 ↗
• MalfunctionAug 8, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT UPON RETURNING TO THE WARD ON THE DAY OF THE OPERATION, THE PATIENT INFORMED THAT THE CATHETER HAD FALLEN OUT, AND HE CONFIRMED THAT IT WAS SPONTANEOUSLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942621 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT SOON AFTER INSERTION (THE EXACT PLACEMENT TIME WAS STILL BEING CONFIRMED), AND IN THE DIRECTOR'S CASE, THREE CONSECUTIVE CASES IN THE SAME PATIENT (20FR , 18FR X 1), A STONE HAS COME OUT AND SAID THAT THE CUFF SHOULD NOT BE DAMAGED BECAUSE OF THAT, AND HAVE HAD MAJOR TROUBLE WITH THIS DIRECTOR'S CASE IN THE PAST DUE TO A BALLOON MALFUNCTION. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16JUL2024, IT WAS REPORTED THAT THE DAMAGE TO THE CUFF WHICH WAS VISIBLE TO THE NAKED EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791880 ↗
• MalfunctionFeb 23, 2023Calcified; Calcified

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION, HEMATURIA LASTING GREATER THAN 24 HOURS, BLADDER FISTULA AND BLADDER PERFORATION PRIOR TO THE DEVICE PLACEMENT, HEMATURIA LASTING GREATER THAN 24 HOURS, BLADDER FISTULA, BLADDER TRAUMA, BLADDER PERFORATION AND CALCIFICATION AFTER THE DEVICE PLACEMENT AND BLADDER TRAUMA COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 18. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428569 ↗
• MalfunctionFeb 22, 2023Calcified; Calcified

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED THAT THE PATIENT HAD URINARY TRACT INFECTION, HEMATURIA LASTING GREATER THAN 24 HOURS, BLADDER FISTULA AND BLADDER PERFORATION PRIOR TO THE DEVICE PLACEMENT, HEMATURIA LASTING GREATER THAN 24 HOURS, CALCIFICATION, BLADDER FISTULA, BLADDER TRAUMA AND BLADDER PERFORATION AFTER THE DEVICE PLACEMENT, AND BLADDER TRAUMA COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE FOLEY CATHETER AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418387 ↗
• MalfunctionFeb 22, 2023Calcified; Calcified

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION, HEMATURIA LASTING GREATER THAN 24 HOURS, BLADDER FISTULA AND BLADDER PERFORATION PRIOR TO THE DEVICE PLACEMENT, HEMATURIA LASTING GREATER THAN 24 HOURS, BLADDER FISTULA, BLADDER TRAUMA , BLADDER PERFORATION) AND CALCIFICATION AFTER THE DEVICE PLACEMENT AND HEMATURIA LASTING GREATER THAN 24 HOURS COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND FISTULA WAS NEEDED IN RELATION TO LUBRICATH®, 3-WAY, 5CC BALLOON, FRENCH SIZE 18. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418386 ↗