Bardex®Lubricath® Foley Catheter Alcock Model 0134L18Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741018756), received between Sep 10, 2018 and Sep 1, 2023 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER WITHDREW WHEN RETURNING TO THE WARD AFTER USE. THEN THE BALLOON WAS RUPTURED. THERE WERE NO MISSING PIECES. THERE WERE NO REMAINS IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671146 ↗
• MalfunctionMay 15, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT STERILE WATER DID NOT ENTER THE FOLEY CATHETER THROUGH THE INFLATION VALVE. INJECTING STERILE WATER FROM THE INFLATION VALVE AFTER THE FOLEY CATHETER INSERTION TO THE PATIENT, THE WATER WAS UNABLE TO INJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931339 ↗
• MalfunctionApr 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST. THE CATHETER FELL OFF AFTER INSERTION TO THE PATIENT. UPON CHECKING THE CATHETER, THE BALLOON WAS FOUND BURST. THE EVENT OCCURRED AFTER 5 HOURS OF PLACEMENT TO THE PATIENT. NO MATERIALS POSSIBLY CAME IN CONTACT WITH THE CATHETER. THERE WAS NO PATIENT URINE STONE, AND THE CATHETER WAS NOT PULLED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706907 ↗
• MalfunctionNov 28, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF THE PATIENT DUE TO STERILE WATER LEAKAGE. THE CATHETER WAS INSERTED TO THE PATIENT AFTER OPERATION AND THERE WAS NO PROBLEM DURING THE PRETEST. HOWEVER, WHEN THE PATIENT RETURNED TO THE WARD, THE CATHETER HAD FALLEN OFF. WHEN THE USER CHECKED THE CATHETER AGAIN, WATER LEAKED FROM THE DRAINAGE FUNNEL. IT WAS STATED THAT THE EVENT HAPPENED SIX HOURS AFTER PLACEMENT. THERE WAS NO RUPTURE OR TEAR IN THE BALLOON. WATER LEAKED FROM THE DRAINAGE EYE INTO THE INLET TUBE. NO MATERIALS WERE POSSIBLY THERE IN CONTACT WITH THE CATHETER AND THE CATHETER WAS INSERTED BY HAND. IT WAS MENTIONED THAT HEALTH HAZARDS TO THE PATIENT WERE UNKNOWN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 22-NOV-2022, STATED THAT THERE WERE NO HEALTH DAMAGES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869731 ↗
• MalfunctionJul 26, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE FOLEY BALLOON AND THE CATHETER FELL OUT ON THE 14TH DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103542 ↗
• MalfunctionMar 9, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON WAS DAMAGED AND THE FOLEY CATHETER FELL OUT ON THE DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716627 ↗
• MalfunctionNov 22, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING CLEANSING, THE FOLEY CATHETER SPONTANEOUSLY FELL OUT 1 DAY AFTER THE PLACEMENT. THE BALLOON HAD RUPTURED. ON (B)(6)2021 THE CATHETER WAS PLACED, THE PATIENT HEARD A CLICKING SOUND FROM THE PATIENT'S BLADDER ON THAT DAY. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6)2021, ON (B)(6)2021, THE FOLEY CATHETER WAS PLACED AND THE CATHETER FELL OUT ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852950 ↗
• MalfunctionNov 19, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AFTER INSERTING THE FOLEY CATHETER IN THE OPERATION ROOM, THE CATHETER FELL OUT AFTER PLACEMENT. PER FOLLOW UP INFORMATION RECEIVED ON 09NOV2021, IT WAS UNKNOWN IF THERE WAS ANY MISSING PIECES LEFT INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843447 ↗
• MalfunctionAug 19, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT INFLATION VALVE OF THE FOLEY CATHETER GOT BROKEN. SO, THE SYRINGE WAS UNABLE TO CONNECT WITH THE INFLATION VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344800 ↗
• MalfunctionJul 8, 2021Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT WHEN THE SYRINGE WAS SET INTO THE INFLATION VALVE, THE VALVE WAS BROKEN AND WATER WAS UNABLE TO INJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135908 ↗
• MalfunctionJun 29, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BADEX BIOCAS FOLEY CATHETER PLACED IN THE OPERATING ROOM FOR PATIENT ON 6/2, DUE TO BALLOON RUPTURE AND WATER LEAK THE CATHETER FELL OUT AND REMOVED FROM PATIENT SPONTANEOUSLY ON THE MORNING OF 6/4. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085562 ↗
• MalfunctionJun 21, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A CUT FOUND ON THE CATHETER TIP UPON OPENING THE PACKAGE. STATED THAT THE DEVICE WAS NOT USED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2021, IT WAS CONFIRMED THAT THERE WAS A TEAR ON THE CATHETER SHAFT NEAR THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035470 ↗
• MalfunctionJul 22, 2020Deflation Problem; Component Missing; Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CATHETER BALLOON DIFFICULT TO DEFLATE SOME TIME AFTER THE PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC VIA EMAIL ON 11MAY2020, IT WAS UNKNOWN HOW THE CATHETER WAS REMOVED FROM THE PATIENT. PER IBC SAMPLE EVALUATION, THE BALLOON LOOKS TO BE INTACT. PER SAMPLE EVALUATION ON 01JUL2020, THE CATHETER FOUND TO BE MISSING AN IRRIGATION EYE.

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

  MAUDE report 10308921 ↗
• MalfunctionMay 20, 2020Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO DEFLATE SOME TIME AFTER PLACEMENT. HOWEVER, AS PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC VIA EMAIL 11MAY2020; IT WAS UNKNOWN HOW THE CATHETER WAS REMOVED FROM THE PATIENT. PER IBC SAMPLE EVALUATION THE BALLOON LOOKS TO BE INTACT. PER SAMPLE EVALUATION ON 01JUN2020, THE CATHETER WAS FOUND TO BE MISSING AN IRRIGATION EYE.

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

  MAUDE report 10074384 ↗
• MalfunctionApr 8, 2020Misassembled; Defective Device; Misassembled

  IT WAS REPORTED FROM AN INVESTIGATOR THAT WHILE INVESTIGATING THE SAMPLE, IT WAS FOUND THAT THE DRAINAGE EYES OF THE CATHETER WERE PLACED TOO FAR FROM THE TIP OF THE CATHETER. ALSO, THE DRAINAGE EYES WERE TOO LARGE WHEN MEASURED.

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

  MAUDE report 9934227 ↗
• MalfunctionApr 6, 2020Incorrect Measurement; Manufacturing, Packaging or Shipping Problem; Incorrect Measurement

  IT WAS REPORTED FROM AN INVESTIGATOR THAT WHILE INVESTIGATING THE SAMPLE FROM A COMPLAINT, THE DRAINAGE EYES OF THE CATHETER WERE PLACED TOO FAR FROM THE TIP OF THE CATHETER. THE DRAINAGE EYES WERE ALSO TOO LARGE WHEN MEASURED.

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

  MAUDE report 9930629 ↗
• MalfunctionMar 5, 2020Burst Container or Vessel; Deflation Problem; Device Slipped; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT DUE TO A DEFLATED BALLOON. IT OCCURRED ON THE DAY OF PLACEMENT. PER ADDITIONAL INFORMATION FROM THE INVESTIGATOR VIA EMAIL 25MAR2020; UPON EVALUATION OF THE SAMPLE A BURST BALLOON WAS OBSERVED, WITH NO MISSING PIECES.

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

  MAUDE report 9794587 ↗
• MalfunctionMar 5, 2020Break; Burst Container or Vessel; No Flow; Material Split, Cut or Torn; Burst Container or Vessel

  IT WAS REPORTED THAT THERE WAS NO URINE FLOW IN THE INLET TUBE, AND THE BALLOON WAS DAMAGED AND TORN.

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

  MAUDE report 9794354 ↗
• MalfunctionMar 4, 2020Break; Restricted Flow rate; Material Split, Cut or Torn; Restricted Flow rate

  IT WAS REPORTED THAT THERE WAS NO URINE FLOW IN THE INLET TUBE, AND THE BALLOON WAS DAMAGED AND TORN.

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

  MAUDE report 9786829 ↗
• MalfunctionDec 18, 2019Burst Container or Vessel; Device Fell

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST AND FELL OUT OF THE PATIENT SOME TIME AFTER PLACEMENT. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL 02DEC2019, THERE WERE NO MISSING PIECES TO THE BURST BALLOON.

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

  MAUDE report 9491666 ↗
• MalfunctionNov 6, 2019Deflation Problem; Device Fell; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WITH A BALLOON DEFLATED 2 DAYS AFTER PLACEMENT.

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

  MAUDE report 9284815 ↗
• MalfunctionSep 26, 2019Deflation Problem; Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE AND DEFLATE THE CATHETER BALLOON.

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

  MAUDE report 9124947 ↗
• MalfunctionAug 14, 2019Burst Container or Vessel; Fluid/Blood Leak; Material Rupture; Burst Container or Vessel

  IT WAS REPORTED THAT A WATER LEAK WAS FOUND WHEN THE CATHETER DEFLATED. .

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

  MAUDE report 8892703 ↗
• MalfunctionJul 17, 2019Break; Break; Crack

  IT WAS REPORTED THAT WATER LEAKED FROM THE SHAFT OF THE CATHETER. ALLEGEDLY, THERE WAS A CRACK ON THE SHAFT.

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

  MAUDE report 8798823 ↗
• MalfunctionSep 10, 2018Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON.

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

  MAUDE report 7862072 ↗