Bardex®Lubricath® Foley Catheter Alcock Model 0134L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741018763), received between Apr 13, 2017 and Dec 13, 2024 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (4 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT AFTER PLACEMENT OF FOLEY CATHETER, URINE DID NOT FLOW. AFTER REMOVAL, THE URINE FLOWED AFTER FLUSHING WITH STERILE DISTILLED WATER. HOWEVER, THE HOSPITAL REQUESTED TO INVESTIGATE THE PRODUCT TO SEE IF THERE WAS A DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924607 ↗
• MalfunctionJul 5, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT STERILE WATER COULD NOT BE INJECTED WHEN ATTEMPTED TO INJECT AFTER THE CATHETER INSERTION. ACCORDING TO THE INQUIRY SHEET ATTACHED, THE PRETEST WAS NOT DONE AND THERE WAS NO PROBLEM OBSERVED DURING INFLATION OF THE CATHETER. THE INFLATION FUNNEL DID NOT SWELL AND THERE WAS NO ABNORMALITY OBSERVED WITH THE SHAFT. USUALLY THE BALLOON COULD BE INFLATED WITHIN SECONDS, BUT SINCE THE PLUNGER COULD NOT BE PUSHED, THE BALLOON COULD NOT BE DEFLATED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2023, IT WAS REPORTED THAT WATER WAS UNABLE TO INJECT INTO THE CATHETER. THE PLUNGER ISSUE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255271 ↗
• MalfunctionFeb 10, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT WATER LEAKED OUT FROM THE VALVE OF THE FOLEY CATHETER DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351893 ↗
• MalfunctionSep 12, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER SPONTANEOUSLY FELL OUT ON THE NEXT DAY AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401281 ↗
• MalfunctionJun 2, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS BROKEN. THE DEVICE WAS USED ON THE PATIENT. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2021, STATED THAT THE DEVICE WAS USED ON THE PATIENT. PER SAMPLE EVALUATION FROM THE INVESTIGATOR VIA EMAIL ON (B)(6) 2022, THE CATHETER WAS FOUND TO HAVE A PINHOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14574779 ↗
• MalfunctionApr 18, 2022Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE USER INSERTED THE FOLEY CATHETER INTO THE PATIENT AND TRIED TO INSERT THE SYRINGE INTO THE INFLATION VALVE BUT CONFIRMED THAT THE VALVE WAS BROKEN. ALTHOUGH THE VALVE WAS DAMAGED, WHEN THE USER TRIED TO INJECT STERILE WATER BY INSERTING THE SYRINGE, THE STERILE WATER LEAKED FROM THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136403 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS BROKEN. THE DEVICE WAS USED ON THE PATIENT. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 30NOV2021, STATED THAT THE DEVICE WAS USED ON THE PATIENT. PER SAMPLE EVALUATION FROM THE INVESTIGATOR VIA EMAIL ON 14MAY2022, THE CATHETER WAS FOUND TO HAVE A PINHOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927648 ↗
• MalfunctionNov 19, 2021Material Protrusion/Extrusion; Component Misassembled; Material Protrusion/Extrusion; Component Misassembled

  IT WAS REPORTED THAT URINE WAS NOT FLOWING AFTER THE PLACEMENT OF FOLEY CATHETER. UPON REMOVAL, IT WAS FOUND THAT THE EYELET WAS NOT OPENED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 28OCT2021, STATED THAT THE EYELETS WERE NOT OPENED BEFORE THE PLACEMENT OF CATHETER. AS PER THE PHOTO SAMPLE RECEIVED, THERE WAS A WHITE BUMP ON THE DRAINAGE FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846696 ↗
• MalfunctionNov 9, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT URINE WAS NOT FLOWING AFTER THE PLACEMENT OF FOLEY CATHETER. UPON REMOVAL, IT WAS FOUND THAT THE EYELET WAS NOT OPENED. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 28OCT2021, STATED THAT THE EYELETS WERE NOT OPENED BEFORE THE PLACEMENT OF CATHETER. AS PER THE PHOTO SAMPLE RECEIVED, THERE WAS A WHITE BUMP ON THE DRAINAGE FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782845 ↗
• MalfunctionOct 28, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE FOLEY CATHETER AFTER THE PLACEMENT. ALSO STATED THAT WHEN THE USER CHECKED THE CATHETER, THE SHAFT WAS FOUND TO BE BROKEN AND CONFIRMED THAT THERE WAS NO PROBLEM AT THE TIME OF THE PRETEST. IT WAS ALSO MENTIONED THAT THERE WAS A BALLOON RUPTURE OR TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712667 ↗
• MalfunctionOct 28, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE WATER LEAKED FROM THE FOLEY CATHETER AFTER THE PLACEMENT. STATED THAT WHEN THE USER CHECKED THE CATHETER, THE SHAFT WAS FOUND TO BE BROKEN. ALSO CONFIRMED THAT THERE WAS NO PROBLEM AT THE TIME OF PRETEST. IT WAS ALSO MENTIONED THAT THERE WAS A BALLOON RUPTURE OR TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712425 ↗
• MalfunctionMar 16, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS FOUND TO BE DAMAGED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496608 ↗
• MalfunctionDec 23, 2020Decrease in Pressure; Decrease in Pressure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11066084 ↗
• MalfunctionNov 10, 2020Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE USER ATTEMPTED TO FLUSH THE PATIENT'S BLADDER AND WATER WAS UNABLE TO REFLUX.

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

  MAUDE report 10816321 ↗
• MalfunctionSep 18, 2020Decrease in Pressure; Device Slipped; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER FELL OUT AFTER THE PLACEMENT.

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

  MAUDE report 10555496 ↗
• MalfunctionJul 21, 2020Fluid/Blood Leak; Decrease in Pressure; Device Fell; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT ALLEGEDLY DUE TO WATER LEAK AFTER THE PLACEMENT.

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

  MAUDE report 10302632 ↗
• MalfunctionApr 1, 2020No Flow; Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CATHETER LUMEN WAS BLOCKED. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL (B)(6) 2020, THE IBC PERSON SAID THAT IT LOOKED AS THOUGH THE IRRIGATION EYE WAS BLOCKED.

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

  MAUDE report 9914258 ↗
• MalfunctionJan 29, 2020Misassembled; Device Damaged Prior to Use; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Misassembled

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON THE CATHETER WHEN THE PACKAGE WAS OPENED. IT WAS LATER REPORTED FROM THE INTERNATIONAL BUSINESS CENTER REPRESENTATIVE ON (B)(6) 2020, THE CATHETER DRAINAGE EYES WERE FOUND TO BE TO FAR FROM THE CATHETER TIP.

  Patient problems: No Patient Involvement

  MAUDE report 9644425 ↗
• MalfunctionNov 5, 2019Complete Blockage; Inability to Irrigate

  IT WAS REPORTED THAT THE CATHETER COULD NOT BE IRRIGATED DUE TO THE IRRIGATION LUMEN BEING BLOCKED.

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

  MAUDE report 9280084 ↗
• MalfunctionOct 9, 2019Misassembled; Output above Specifications; Misassembled

  IT WAS REPORTED THAT THE URINE FLOW WAS LIMITED. PER EMAIL RECEIVED FROM THE IBC REPRESENTATIVE ON (B)(6)2019 , YES, THERE WAS A LITTLE URINE FLOW, BUT ALLEGEDLY THE FLOW WAS NOT SMOOTH AND PROPERLY. PER EMAIL RECEIVED FROM THE INVESTIGATOR ON (B)(6)2019, IT WAS FOUND THE THAT THE LENGTH OF BOTH DRAINAGE EYES FROM THE TIP WAS ABOVE SPECIFICATIONS FOR BOTH CATHETERS.

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

  MAUDE report 9172283 ↗
• MalfunctionJun 11, 2019Inability to Irrigate; Inflation Problem; Inability to Irrigate

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INJECT WATER TO THE BLADDER WASHING. AFTER REMOVED, THE USER CUT THE TIP OF THE CATHETER OFF TO CONFIRM THE PRODUCT.

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

  MAUDE report 8687588 ↗
• MalfunctionSep 11, 2018Inability to Irrigate

  IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO IRRIGATE THROUGH THE IRRIGATION LUMEN.

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

  MAUDE report 7864495 ↗
• MalfunctionSep 6, 2018Inflation Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT IT WAS DIFFICULT TO INFLATE THE BALLOON DURING A PRETEST.

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

  MAUDE report 7850414 ↗
• MalfunctionAug 2, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE USER FOUND THE STEM OF THE INFLATION VALVE ON THE CATHETER WAS DEPRESSED WHEN THE PACKAGE WAS OPENED. REASON FOR REPORT: INVESTIGATION RESULTS. REPORT ID NUMBER: (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Patient Involvement

  MAUDE report 7742837 ↗
• MalfunctionJul 25, 2018Inflation Problem

  IT WAS REPORTED THAT WATER WOULDN'T BE INJECTED INTO THE BALLOON OF CATHETER BEFORE USE. REASON FOR REPORT: INVESTIGATION RESULTS. (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718038 ↗