Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0102L18Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741018138), received between Jul 25, 2017 and Jul 7, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ON (B)(6) 2025, PATIENT MRN# (B)(6) WAS BROUGHT TO OPERATING ROOM #1 FOR A CYSTOSCOPY AND INSERT URETERAL CATHETERS BY THE PHYSICIAN AND A LAPAROSCOPIC LOW ANTERIOR RECTUM RESECTION BY ANOTHER PHYSICIAN. DURING THE CYSTOSCOPY PHYSICIAN WAS UNABLE TO INSERT THE URETERAL CATHETERS BUT WAS ABLE TO PLACE AN 18 FRENCH FOLEY REF# (B)(4). AT THE START OF THE PART OF THE PROCEDURE THE FOLEY DID NOT STAY IN THE PATIENT AND FELL OUT OF THE PATIENT. ON REQUEST OF THE PHYSICIAN ANOTHER FOLEY WAS BROUGHT INTO THE ROOM AND PLACED IN THE PATIENT. THAT WAS A 16 FRENCH FOLEY REF# (B)(4), AS THE PROCEDURE WAS GOING ON THAT FOLEY FELL OUT AS WELL. TWO MORE 16 FRENCH FOLEYS WERE PLACED REF# (B)(4) WITH THE SAME RESULTS. AND THEN ATTEMPTED TO PLACE A 16 FRENCH 2WAY COUDE REF# (B)(4) AND 18 FRENCH 2WAY COUDE REF# (B)(4) WITH THE SAME RESULTS. PHYSICIAN WAS ASKED TO ASSIST AT THIS POINT AND WAS ABLE TO SUCCESSFULLY PLACE A 20 FRENCH 2WAY COUDE REF# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413392 ↗
• MalfunctionJun 23, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT CUSTOMER USING FOLEY CATHETERS AND HAVING TROUBLES WITH THE BALLOON NOT FULLY INFLATING AND ACTING AS THOUGH THERE WAS A KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309222 ↗
• MalfunctionApr 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS FOUND IN 4 PIECES AND IT WAS NOT KEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865825 ↗
• MalfunctionApr 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLEY CATHETER WAS INSERTED ON (B)(6) 2025 AND ON (B)(6) 2025 CATHETER CAME OUT AND NOTED THAT THE Y CONNECTION ON SECTION WHERE BALLON WAS INFLATED WAS FRAYED AND BROKE APART FULLY INTO TWO PIECES AND CAUSED THE BALLOON TO DEFLATE AND THE CATHETER EASILY PULLED OUT BY RESIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848846 ↗
• MalfunctionJul 23, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD NUMEROUS BARD 18 FR COUDE CATHETERS (LOT# UNK- DOE UNK). THE BALLOONS BECAME DEFLATED AND ESSENTIALLY FALLING OUT. MOST RECENTLY, THERE WAS AN AUDIBLE HISSING SOUND WHEN ATTEMPTING TO REINFLATE ONE OF THESE BALLOONS. (LOT# NGJR0021- DOE (B)(6) 2024).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805165 ↗
• MalfunctionJul 23, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD NUMEROUS BARD 18 FR COUDE CATHETERS (LOT# UNK- DOE UNK). THE BALLOONS BECAME DEFLATED AND ESSENTIALLY FALLING OUT. MOST RECENTLY, THERE WAS AN AUDIBLE HISSING SOUND WHEN ATTEMPTING TO REINFLATE ONE OF THESE BALLOONS. (LOT#NGJR0021 - DOE 09JUL2024).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805136 ↗
• MalfunctionJun 17, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD A RECENT ISSUE. A PATIENT WAS GIVEN A 5CC CATHETER TO GO HOME WITH, BUT THAT PATIENT CAME BACK TO THE FACILITY BECAUSE IT FELL OUT. STAFF NOTICED THAT THE OUTER PACKAGE LISTED A 5CC BALLOON, BUT PRINTED ON THE PHYSICAL CATHETER ITSELF, IT INDICATED TO INFLATE WITH 10ML. THOSE DIFFERENCES CAUSED CONCERN FOR THEIR CLINICIANS, AND THEY WANTED TO MAKE SURE THIS WAS NOT A MISTAKE OR CONFIRM HOW THE CLINICIANS SHOULD BE INFLATING THESE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546986 ↗
• MalfunctionJan 24, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER PORTS FELL OFF AND WERE PLACED ONTO THE CATHETER CROOKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233175 ↗
• MalfunctionDec 27, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND A HOLE WAS DISCOVERED AT Y-SITE ON BALLOON PORT, NOTICED WITH INFLATING BALLOON. THE CATHETER HAD TO BE DISCONTINUED AS THE USER WAS UNABLE TO INFLATE BALLOON. A SECOND CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051602 ↗
• MalfunctionAug 2, 2022Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER HAD A HOLE IN ONE OF THE BALLOONS IN THE FOLEY CATHETER WHEN THEY OPENED THE PACKAGING OF ONE OF THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147002 ↗
• MalfunctionMay 25, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD AN UNKNOWN ISSUE. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 06MAY2022, IT WAS STATED THAT THE PATIENT INDICATED THEY HAD FELT A POP DAYS PRIOR TO THE CATHETER COMING OUT AND THE PATIENT WAS PRESENTED TO AN EMERGENCY DEPARTMENT REQUIRING A REINSERTION OF A COUDE CATHETER. A NEW CATHETER WAS INSERTED IN THE EMERGENCY DEPARTMENT AT WHICH THE PATIENT PRESENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496339 ↗
• MalfunctionOct 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN THAT CAUSED THE BALLOON TO DEFLATE AND THE CATHETER TO FELL OUT. IT WAS ALSO STATED THAT THE PLASTIC SHEATH REMAINED INTACT ON ONE SIDE OF THE CATHETER THAT PREVENTED THE PIECES OF THE CATHETER FROM BEING RETAINED IN THE BLADDER. AS PER THE FOLLOW-UP INFORMATION RECEIVED ON 18SEP2020, THE PATIENT CONFIRMED THAT NO ADVERSE EFFECT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10685515 ↗
• MalfunctionAug 14, 2020Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE RED RUBBER LATEX FOLEY BALLOON WOULD NOT INFLATE.

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

  MAUDE report 10408089 ↗
• MalfunctionJun 5, 2020Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THERE WERE NO DRAINAGE EYES ON THE CATHETER.

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

  MAUDE report 10125389 ↗
• MalfunctionApr 22, 2020Difficult to Insert

  IT WAS REPORTED THAT THE FOLEYS WERE TOO PAINFUL DURING INSERTION. IT IS UNKNOWN IF THE PATIENT WAS ABLE TO VOID.

  Patient problems: Pain

  MAUDE report 9986562 ↗
• MalfunctionFeb 5, 2020Burst Container or Vessel; Device Fell; Burst Container or Vessel

  IT WAS REPORTED THAT THE COUDE CATHETER FELL OUT OF THE PATIENT ON (B)(6) 2019 AFTER BEING PLACED ON (B)(6) 2019. THE PATIENT WENT BACK TO THE EMERGENCY ROOM TO HAVE A NEW CATHETER PLACED. PER FOLLOW UP WITH PATIENT'S WIFE ON (B)(6) 2020, IT WAS REPORTED THAT THE BALLOON BURST THE DAY AFTER PLACEMENT, CAUSING IT TO FALL OUT OF THE PATIENT PREMATURELY. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) DUE TO DIFFICULTY URINATING AND PAIN. THE PATIENT ALSO EXPERIENCED ELEVATED BLOOD PRESSURE (193/92) WHEN VITALS WERE CHECKED IN THE ER DURING HIS VISIT. THE ER NURSE REPLACED THE CATHETER AND ADVISED THE PATIENT TO KEEP THE NEW CATHETER IN PLACE FOR 5 DAYS. THERE WAS NO REPORTED MEDICAL INTERVENTION AND THE PATIENT IS CURRENTLY HAVING NO SIDE EFFECTS DUE TO THE REPORTED EVENT.

  Patient problems: High Blood Pressure/ Hypertension; No Code Available; Pain; Patient Problem/Medical Problem

  MAUDE report 9671923 ↗
• InjuryJan 21, 2020Misassembled; Defective Component; Component Missing; No Flow; Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED INTO A PATIENT AND THERE WAS NO URINE OUTPUT. A BLADDER SCAN WAS REPORTEDLY PERFORMED, AND REVEALED SIGNIFICANT URINE IN THE BLADDER. THE CATHETER WAS REPORTEDLY REPLACED AND OVER 300 CC OF URINE DRAINED. UPON REMOVAL, IT WAS NOTED THAT THERE WAS NO EXIT HOLE ON THE FOLEY. THE CATHETER WAS REPORTEDLY IN USE FOR JUST OVER 24 HOURS.

  Patient problems: No Information; Urinary Retention

  MAUDE report 9612508 ↗
• MalfunctionMar 18, 2019Break; Fluid/Blood Leak; Material Puncture/Hole; Break

  IT WAS REPORTED THAT THE LUBRICATH FOLEY CATHETER LEAKED URINE FROM HOLES IN THE CATHETER.

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

  MAUDE report 8429405 ↗
• MalfunctionJul 12, 2018Deflation Problem; Fluid/Blood Leak; Deflation Problem

  IT WAS REPORTED THAT WATER LEAKED FROM THE SHAFT OF THE CATHETER DURING A PRETEST.

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

  MAUDE report 7684480 ↗
• MalfunctionFeb 7, 2018Deflation Problem

  IT WAS REPORTED THAT THE CATHETER BALLOON DEFLATED ON IT'S OWN. NO MISSING PIECES WERE REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7247160 ↗
• MalfunctionJul 25, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING FROM AN UNKNOWN SOURCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742970 ↗