Bardex Lubricath Temperature-Sensing Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 177
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 0
We found 5 models of Bardex Lubricath Temperature-Sensing Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2017 and Sep 9, 2026 — classified as 50 injuries, 127 malfunctions.
The most frequently reported specific device problem is “Partial Blockage” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardex Lubricath Temperature-Sensing Foley Catheter problems
Device problems
- Partial Blockage25
- Fluid/Blood Leak24
- Adverse Event Without Identified Device or Use Problem22
- Erratic or Intermittent Display14
- Inaccurate Flow Rate14
- Patient Device Interaction Problem14
- Difficult to Remove7
- Failure to Infuse7
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available30
- Urinary Tract Infection19
- No Consequences Or Impact To Patient18
- No Known Impact Or Consequence To Patient18
- Hematuria12
- Pain11
- Discomfort5
Bardex Lubricath Temperature-Sensing Foley Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 67 reports
- Bardex® Lubricath® Temperature-Sensing Foley Catheter 117416CATHETER, COUDE58 reports
- Bardex® Lubricath® Temperature-Sensing Foley Catheter 119416CATHETER, COUDE45 reports
- Bardex® Lubricath® Temperature-Sensing Foley Catheter 119418CATHETER, COUDE6 reports
- 1 report
Recent Bardex Lubricath Temperature-Sensing Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Deformation Due to Compressive Stress
Patient problems: Exposure to Body Fluids
MAUDE report 50702131 ↗MalfunctionJul 15, 2026Material Twisted/Bent
It was reported by customer that after placing Temperature Sensing Foley Catheter the RN discovered that the temperature probe appeared damaged and/or crushed. The foley catheter was removed, and a new foley catheter was placed that had a functional temperature probe. The patient experienced discomfort due to the removal and replacement of the foley catheter. There is no known harm to the patient at this time.Per customer via email on (b)(6) 2026 the lot number is NGLQ0447 and serial number (b)(6). Upon discovery of the temp probe being damaged and nonfunctional, the foley catheter had to be removed and replaced. This caused a delay in care and discomfort to the patient due to the removal and replacement of the catheter.
Patient problems: Discomfort; Insufficient Information
MAUDE report 25826332 ↗MalfunctionApr 1, 2026Unclear Information
IT WAS REPORTED THAT THE CUSTOMER REACHED OUT REGARDING AN IMPORTANT PRODUCT DISCREPANCY FOR THE BARD TEMPERATURE SENSING CATHETER, PRODUCT #119416M UNDER CONTRACT #(B)(4). THE OUTER PACKAGING INDICATES THE CATHETER HAS A 5CC BALLOON, WHILE THE CATHETER ITSELF IS LABELED 10CC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758838 ↗InjuryMar 18, 2026Difficult to Remove
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD BEEN DEFLATED WITH 10 CC PRIOR TO REMOVAL. THE WRITER HAD ATTEMPTED TO REMOVE THE FOLEY CATHETER AT THE BEDSIDE, BUT RESISTANCE HAD BEEN ENCOUNTERED AT THE MEATUS OF PENIS. THE WRITER NOTIFIED THE CHARGE NURSE, AND WITH THE CHARGE NURSE¿S ASSISTANCE, ATTEMPTED TO READVANCE THE CATHETER AND REMOVE IT AGAIN; HOWEVER, RESISTANCE HAD AGAIN BEEN MET. THE PHYSICIAN ASSISTANT WAS NOTIFIED, AND THE FOLEY WAS LEFT IN PLACE. THE FOLEY CATHETER WAS LATER REMOVED BY THE PHYSICIAN ASSISTANT WITH SUPPORT FROM THE UROLOGY SERVICE, THOUGH THIS REMOVAL WAS NOT WITNESSED BY THE WRITER. AFTER REMOVAL, THE PATIENT HAD REPORTED 9/10 PAIN, AND A SMALL AMOUNT OF BLOOD DRAINAGE HAD BEEN NOTED DURING ASSESSMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 24633254 ↗InjuryFeb 25, 2026Difficult to Remove
IT WAS REPORTED THAT THEY HAD 3 ISSUES NOW WITHIN THE LAST 1.5 TO 2 WEEKS WITH MONO THERM FOLEY CATHETERS BEEN VERY HARD TO REMOVE AND NOT ALLOWING BLADDER EMPTYING. THE MANUFACTURER NUMBER WAS A119416M AND LOT NUMBER IS NGKX5727. FROM WHAT WAS WRITTEN IN THEIR INTERNAL REPORTING MEMO, FOLEY WAS ORDERED TO BE REMOVED AND THE NURSE, AFTER MULTIPLE ATTEMPTS AT DRAINING THE BALLOON, CALLED UROLOGY TO HAVE IT REMOVED. THE FOLEY WAS EVENTUALLY REMOVED WITH SOME FORCE APPLIED BY UROLOGY. (LOT NGKX5727) AND (LOT UNK).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24448081 ↗InjuryFeb 25, 2026Difficult to Remove
IT WAS REPORTED THAT THEY HAD 3 ISSUES NOW WITHIN THE LAST 1.5 TO 2 WEEKS WITH MONO THERM FOLEY CATHETERS BEEN VERY HARD TO REMOVE AND NOT ALLOWING BLADDER EMPTYING. THE MANUFACTURER NUMBER WAS A119416M AND LOT NUMBER IS NGKX5727. FROM WHAT WAS WRITTEN IN THEIR INTERNAL REPORTING MEMO, FOLEY WAS ORDERED TO BE REMOVED AND THE NURSE, AFTER MULTIPLE ATTEMPTS AT DRAINING THE BALLOON, CALLED UROLOGY TO HAVE IT REMOVED. THE FOLEY WAS EVENTUALLY REMOVED WITH SOME FORCE APPLIED BY UROLOGY. (LOT NGKX5727) AND (LOT UNK).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24448065 ↗MalfunctionJan 16, 2026No Display/Image
IT WAS REPORTED THAT THAT THE CLINICAL TEAM HAD RECEIVED APPROXIMATELY FOUR COMPLAINTS REGARDING ITEM A344916. THE TEMP SENSING FOLEY CATHETER WAS NOT DISPLAYING THE TEMP ON THE MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093539 ↗InjuryDec 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THERE HAVE SINCE BEEN 3 MORE EVENTS WITH THE SIMILAR SITUATION WHERE THE FOLEY WAS NOT DRAINING APPROPRIATELY. PATIENTS HAVE BEEN BLADDER SCANNED AND FOUND TO HAVE URINE IN THEIR BLADDERS OR EXCHANGE OCCURS AND URINE FLOWS. PER CUSTOMER FOLLOW UP RECEIVED VIA EMAIL ON 04DEC2025 STATED THAT THEY DID BELIEVE THE DEVICE WAS DISCARDED AND 1 MAY HAVE BEEN PICKED UP BY CLINICAL ENGINEERING. PATIENT RETAINED URINE AND ALL DEVICES HAD TO BE REMOVED AND REPLACED TO ALLOW URINE TO FLOW ADEQUATELY. THAT WAS AS MUCH INFORMATION THEY HAD AT HAND. THEY WOULD NEED TO GO BACK INTO CHARTS AND REVIEW GENDER AND AGES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23705781 ↗InjuryDec 3, 2025Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THERE HAD SINCE BEEN 3 MORE EVENTS WITH THE SIMILAR SITUATION WHERE THE FOLEY CATHETER WAS NOT DRAINED APPROPRIATELY. PATIENTS HAD BEEN BLADDER SCANNED AND FOUND TO HAVE URINE IN THEIR BLADDERS OR EXCHANGE OCCURS AND URINE FLOWS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23705776 ↗InjuryDec 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THERE HAD SINCE BEEN 3 MORE EVENTS WITH THE SIMILAR SITUATION WHERE THE FOLEY CATHETER WAS NOT DRAINED APPROPRIATELY. PATIENTS HAD BEEN BLADDER SCANNED AND FOUND TO HAVE URINE IN THEIR BLADDERS OR EXCHANGE OCCURS AND URINE FLOWS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23701284 ↗InjuryNov 24, 2025Complete Blockage; Component Misassembled; Complete Blockage; Component Misassembled
IT WAS REPORTED THAT REPORTING NURSE HIT ROOM READY AT 0822. REPORTING NURSE WAS AT PRE OPERATING ROOM AT 0823. BLOCK WAS STILL BEING COMPLETED BY ANESTHESIA AT THAT TIME. BLOCK ENDED AT 0825 AND PATIENT WAS REPOSITIONED AND TESTED WITH ICE TO CHECK EPIDURAL. WHEN BLOCK ANESTHESIA DEPARTED FROM THE PRE OPERATING ROOM OPERATING ROOM NURSE CHECKED IN TO SEE WHEN IF EVERYONE WAS READY FOR PRE OPERATING HUDDLE. OPERATING ROOM NURSE WAS INFORMED THAT CLIPPING STILL NEEDED TO OCCUR. AT APPROXIMATELY 0831 OPERATING ROOM NURSE PROCEEDED INTO PRE OPERATING BAY TO ASK QUESTIONS OF THE PATIENT. BEFORE OPERATING ROOM NURSE ENTERED THE PRE OPERATING ROOM BAY, THE PATIENT WAS ASSIGNED PRE OPERATING ROOM NURSE TOLD ANOTHER PRE OPERATING NURSE THAT IT WAS VERIFIED HUDDLE BEFORE THEY PAGED SO THAT EVERYTHING WAS WRITTEN DOWN ON PRE-OP HUDDLE SHEET. AS ANESTHESIA RESIDENT AND OR NURSE WERE PRESENT IN PRE-OP BAY WITH PATIENT, PRE-OP HUDDLE WAS COMPLETED WITH A PRE-OP RN THAT WAS NOT ASSIGNED TO THE PATIENT. LAST VOID WAS NEITHER DISCLOSED ON THE SHEET, ABOUT, OR WRITTEN ON THE PRE-OP HUDDLE SHEET UNDER THE PRE-OP URINE COLUMN. PATIENT WAS TRANSPORTED BACK TO THE OR AND ENTERED AT 0840. PRE-INDUCTION
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23639980 ↗MalfunctionJun 30, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT CUSTOMER HAD ANOTHER FAILED SURESTEP FOLEY TRAY, THE TEMPERATURE PROBE WAS NOT SENSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367189 ↗MalfunctionFeb 11, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THEY RECEIVED AN INCIDENT REPORT STATING THAT TWO OF THEIR BALLOONS OF TEMPORARY SENSING FOLEY CATHETER HAD BEEN FILLED WITH 10 MILLILITERS NORMAL SALINE, HOWEVER PATIENT WAS LEAKING URINE. WHEN THEY REMOVED THE FOLEY ONLY 7 MILLILITERS NORMAL SALINE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356767 ↗MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THEY RECEIVED AN INCIDENT REPORT STATING THAT TWO OF THEIR BALLOONS OF TEMPORARY SENSING FOLEY CATHETER HAD BEEN FILLED WITH 10 MILLILITERS NORMAL SALINE; HOWEVER, PATIENT WAS LEAKING URINE. WHEN THEY REMOVED THE FOLEY ONLY 7 MILLILITERS NORMAL SALINE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356765 ↗MalfunctionDec 4, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THEY WERE REACHING OUT BECAUSE THEY RECEIVED A SAFETY REPORT FROM CLINICAL STAFF REGARDING TEMPERATURE SENSING FOLEY CATHETER. THEY DID NOT HAVE A LOT NUMBER, AS THE PACKAGING WAS NOT SAVED. EVENT OCCURRED ON 24OCT2024. FOLEY CATHETER BALLOON WAS DEFECTIVE, THEY WERE UNABLE TO DEFLATE. THERE WAS NO TRAUMA OR INJURY TO PATIENT. TO THEIR KNOWLEDGE, THIS ISSUE HAS ONLY HAPPENED ONCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844327 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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