Bardex® Lubricath® Foley Catheter 0165L24Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741017520), received between May 19, 2017 and Aug 19, 2025 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD A HOLE THE TUBING IS CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841397 ↗
• MalfunctionNov 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED OF A FOLEY CATHETER THAT THE BALLOON HAD FAILED. WHILE INFLATING BALLOON ON 24FR LUBRICOUS CATHETER DURING ROUTINE SPC CHANGE, IT WAS NOTED THAT THE PORT OF THE BALLOON WAS LEAKING. IT WAS A SLOW DRIP AND THEN A STREAM OF FLUID COMING OUT. CATHETER REMOVED AND REPLACED WITH ANOTHER ONE WITH A DIFFERENT LOT NUMBER. PER ADDITIONAL INFORMATION RECEIVED ON 12DEC2024, IT WAS REPORTED THAT THE SPC CHANGE, WHILE INFLATING THE BALLOON THE STERILE WATER STARTED SQUIRTING OUT OF BALLOON PORT, THE TUBING JUST ABOVE THE PORT. THEY NOTED IT AS WERE FILLING THE BALLOON UP AND REMOVED IT IMMEDIATELY AND PLACED A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724270 ↗
• MalfunctionSep 17, 2024Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THEY SHIPPED FOUR FOLEY CATHETERS TO CUSTOMER OF MATERIAL#0165L24 ON (B)(6)2024 AND SAID THREE HAD ISSUES, ONE HAD A HOLE IN IT, ONE WAS BLOCKED AND WOULD NOT ALLOW THE SYRINGE TO DRAIN THE FLUID BACK OUT OF THE BALLOON AND THE THIRD ONE WAS BURST ALL TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237021 ↗
• MalfunctionSep 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THEY SHIPPED FOUR FOLEY CATHETERS TO CUSTOMER OF MATERIAL#0165L24 ON (B)(6) 2024 AND SAID THREE HAD ISSUES, ONE HAD A HOLE IN IT, ONE WAS BLOCKED AND WOULD NOT ALLOW THE SYRINGE TO DRAIN THE FLUID BACK OUT OF THE BALLOON AND THE THIRD ONE WAS BURST ALL TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236376 ↗
• MalfunctionSep 17, 2024Partial Blockage; Difficult to Remove; Partial Blockage; Difficult to Remove

  IT WAS REPORTED THAT THEY SHIPPED FOUR FOLEY CATHETERS TO CUSTOMER OF MATERIAL#0165L24 ON 01AUG2024 AND SAID THREE HAD ISSUES, ONE HAD A HOLE IN IT, ONE WAS BLOCKED AND WOULD NOT ALLOW THE SYRINGE TO DRAIN THE FLUID BACK OUT OF THE BALLOON AND THE THIRD ONE WAS BURST ALL TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236117 ↗
• MalfunctionAug 13, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT CUSTOMER DID NOT WANT TO USE THE DEVICE DUE TO A SERIES OF UNREMOVABLE INCIDENTS OF FOLEY CATHETER. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974423 ↗
• MalfunctionAug 13, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DUE TO THE MANY CASES OF INABILITY TO REMOVE THE DEVICE, THEY DID NOT WANT TO USE PRODUCTS FROM THE SAME LOT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 24JULY2024, CUSTOMER CONFIRMED THAT NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974421 ↗
• InjuryAug 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE REGULAR REPLACEMENT AFTER THE FOLEY CATHETER WAS PLACED IN PLACE FOR 2 WEEKS, THE DISTILLED WATER WAS DIFFICULT TO REMOVE, SO THE BALLOON HAD TO BE BROKEN BY PUNCTURING THE AREA ABOVE THE PUBIC BONE TO REMOVE IT.

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

  MAUDE report 19920777 ↗
• InjuryAug 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE REGULAR REPLACEMENT AFTER THE FOLEY CATHETER WAS PLACED IN PLACE FOR 2 WEEKS, THE DISTILLED WATER WAS DIFFICULT TO REMOVE, SO THE BALLOON HAD TO BE BROKEN BY PUNCTURING THE AREA ABOVE THE PUBIC BONE TO REMOVE IT.

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

  MAUDE report 19917112 ↗
• MalfunctionMay 29, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS UNABLE TO INSERT. PATIENT SAID THAT THEY WERE ABLE TO GET THE REPLACEMENT. PER CUSTOMER ON (B)(6) 2024, IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. CUSTOMER STATES THERE WAS NO IMPACT TO THE PATIENT AND THE FAULTY SAMPLE HAS BEEN THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19416836 ↗
• MalfunctionApr 4, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS UNABLE TO INSERT. PATIENT SAID THAT THEY WERE ABLE TO GET THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040025 ↗
• MalfunctionDec 4, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER HAD A HOLE IN THE BALLOON AND FELL OUT OF THE PATIENT. THERE WAS NO HARM DONE, BUT ANOTHER CATHETER HAD TO BE INSERTED. PER FOLLOW UP ON 05DEC2023, IT WAS REPORTED THAT THE CATHETER HAD A HOLE AND FELL OUT OF THE PATIENT. THE INITIAL CATHETER WAS DISCARDED, AND ANOTHER CATHETER WAS INSERTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255480 ↗
• MalfunctionJul 11, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE URINE WAS NOT CURRENTLY DRAINING AND WAS BACKING UP INTO THE FOLEY CATHETER ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977544 ↗
• MalfunctionJul 7, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT WAS USING A FOLEY CATHETER WITH BALLOON AND THE BALLOON KEPT DEFLATING AND CAUSING THE CATHETER TO COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944617 ↗
• MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER SEEMS TO BE LEAKING AFTER SEVERAL DAYS. IT LEAKED AROUND THE FOLEY CATHETER. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THIS PRODUCT MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779113 ↗
• MalfunctionAug 6, 2021Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER DEFLATED AND FOLDED ONTO ITSELF DEVELOPING STRONG RIDGES, HARD BALLOON, AND CAUSED IT TO ACT AS AN OBSTRUCTION. THIS WAS EXTREMELY PAINFUL TO THE PATIENT AND A CHALLENGE FOR THE PHYSICIAN WHEN THE FOLEY CATHETER WAS REMOVED. THE DOCTOR STATED THAT THIS HAS HAPPENED TWICE IN THE LAST WEEK. NO HARM TO PATIENT.

  Patient problems: Pain

  MAUDE report 12285968 ↗
• MalfunctionApr 13, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER BALLOON CONTINUES TO DEFLATE AND CUSTOMER HAD TO REFILL BALLOON FOR MULTIPLE TIMES PER DAY. PATIENT HAD A DOCTOR APPOINTMENT TO DISCUSS FURTHER REGARDING BARD FOLEY CATHETER INFLATION AND DEFLATION. REPRESENTATIVE ADVISED THAT THE GUIDELINES FOR 5CC BALLOON MUST BE INFLATED BETWEEN 9CC AND 10CC BECAUSE INFLATING IMPROPERLY MIGHT CAUSE DRAINAGE DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656844 ↗
• MalfunctionMar 11, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD A NICK ON IT, WHICH CAUSED THE CATHETER TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468062 ↗
• MalfunctionJan 6, 2021Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE INTERIOR OF THE CATHETER COLLAPSED ON THE BALLOON AND WAS NOT ABLE TO DRAIN. THE BALLOON HAD TO BE DEFLATED TO GET THE DRAINAGE GOING. THE PATIENT HAS ALSO EXPERIENCED SEVERAL BLADDER INFECTIONS AND STATED A FULL BLADDER CAN CAUSE HYPERREFLEXIA, WHICH WAS WHEN THE BLOOD PRESSURE COULD GO UP UNCONTROLLABLY IN A QUADRIPLEGIC PATIENT. IT WAS UNKNOWN WHAT TREATMENT WAS PROVIDED FOR THE INFECTION PER SAMPLE EVALUATION NOTIFICATION FROM THE INVESTIGATOR VIA EMAIL ON 15 DEC 2020, THE CATHETER WAS FOUND TO BE NON CONCENTRIC UPON INFLATING.

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

  MAUDE report 11127511 ↗
• MalfunctionOct 1, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED AROUND THE PENIS.

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

  MAUDE report 10612702 ↗
• MalfunctionJul 6, 2020Decrease in Pressure; Deflation Problem; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON DEFLATED AND THE PATIENT WOKE UP WET. ALSO, THE PATIENT STATED THAT THIS HAD HAPPENED BEFORE AND REPORTED SEVERAL MONTHS AGO.

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

  MAUDE report 10232555 ↗
• MalfunctionApr 29, 2020Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT WHEN THE USER INSERTED THE CATHETER AND ATTEMPTED TO INFLATE THE BALLOON, THE SHAFT INFLATED. THE BALLOON WAS INFLATED WITH 10CC OF STERILE WATER.

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

  MAUDE report 10008967 ↗
• MalfunctionApr 22, 2020Decrease in Pressure; Deflation Problem; Decrease in Pressure; Device Slipped

  IT WAS REPORTED THAT THE PATIENT HAD 2 FOLEY CATHETERS THAT DEFLATED IN ONE DAY. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON (B)(6) 2020, 1 FOLEY CATHETER DEFLATED AND FELL OUT OF THE PATIENT. THE COMPLAINANT NOTED THAT THERE WERE NO HOLES WERE NOTED AND THE CATHETER WAS IN PLACE FOR A LITTLE OVER A WEEK. THE USER THEN REPLACED THE CATHETER AND THE SHAFT INFLATED. THE BALLOON WAS REPORTEDLY INFLATED WITH 10 CC STERILE WATER.

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

  MAUDE report 9986951 ↗
• MalfunctionFeb 19, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT SAID THE BALLOON BURST.

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

  MAUDE report 9726437 ↗
• MalfunctionJul 22, 2019Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED AROUND THE MEATUS.

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

  MAUDE report 8813085 ↗