Bardex Lubricath Foley Catheter Tiemann Model CoudeRecalls & reported problems across all models
C. R. Bard, Inc. · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 11 models of Bardex Lubricath Foley Catheter Tiemann Model Coude by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 161 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Feb 3, 2026 — classified as 21 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (27 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 Foley Catheter Tiemann Model Coude problems
Device problems
- Material Puncture/Hole27
- Deflation Problem23
- Difficult to Remove14
- Fluid/Blood Leak11
- Inflation Problem11
- Material Fragmentation10
- Material Split, Cut or Torn10
- Component Misassembled9
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient28
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available17
- No Patient Involvement9
- Pain8
- Discomfort6
- Hemorrhage/Blood Loss/Bleeding5
Bardex Lubricath Foley Catheter Tiemann Model Coude models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 58 reports
- 38 reports
- 21 reports
- 17 reports
- 7 reports
- Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L14CATHETER, UROLOGICAL6 reports
- Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L16CATHETER, UROLOGICAL4 reports
- Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L18CATHETER, UROLOGICAL3 reports
- Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L24CATHETER, UROLOGICAL3 reports
- 2 reports
- Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L20CATHETER, UROLOGICAL2 reports
Recent Bardex Lubricath Foley Catheter Tiemann Model Coude adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED AND HAD URINE RETURN TO WHICH THAT REGISTERED NURSE INFLATED THE BALLOON OF THE CATHETER; HOWEVER, THE URINE FLOW THEN STOPPED. REGISTERED NURSE AND THE CHARGE REGISTERED NURSE MADE THE DECISION TO REMOVE THAT CATHETER, BUT WHEN THE CHARGE REGISTERED NURSE ATTEMPTED TO DEFLATE THE BALLOON, THE SYRINGE FILLED WITH 3ML OF PURE BLOOD. THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT SUCCESSFULLY AND REGISTERED NURSE AND THE CHARGE REGISTERED NURSE INSPECTED THAT TO FIND A HOLE MID WAY THROUGH THE CATHETER. THE PROVIDER WAS THEN NOTIFIED AND UROLOGY WAS CONSULTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding
MAUDE report 24247500 ↗MalfunctionJan 23, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THEY RECEIVED A CALL FROM THE PATIENT'S DAUGHTER AND STATED THE FOLEY CATHETER ITEM 0102L16, SENT IN NOVEMBER WAS LEAKING WHEN IT WAS BEING USED, POTENTIALLY DUE TO A PRODUCT QUALITY, AND NEEDED TO BE CHANGED EARLY. THEY INDICATED THE ITEM INCLUDED ON PO 2377178 SENT IN DECEMBER DID NOT HAVE THE SAME PRODUCT QUALITY ISSUE. THEY DID NOT HAVE THE PACKAGING FOR EITHER CATHETER FOR A LOT NUMBER. ALSO ASKED, ARE THEY ABLE TO GET A REPLACEMENT QUANTITY 1 OF THE ITEM SENT OUT. THEY DON'T HAVE THE ITEM. NO REPLACEMENT IS NEEDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24165207 ↗MalfunctionDec 4, 2025Disconnection; Disconnection
IT WAS REPORTED THAT WHEN WRITER WAS INSERTING FOLEY CATHETER, SAME WENT TO INFLATE BALLOON AND DESPITE NO RESISTANCE, THE END CAP OF THE BALLOON PORT FLEW OFF. SALINE ALL REMOVED FROM BALLOON AND REMOVED CATHETER AS IT WAS NO LONGER ABLE TO BE USED. NO ACTUAL HARM DONE TO PATIENT, BUT INCREASED RISKS TO PATIENT AS HAD TO HAVE ANOTHER CATHETER INSERTED. BALLOON ITSELF REMAINED INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723075 ↗MalfunctionDec 2, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT WHILE INFLATING THE FOLEY CATHETER BALLOON, WRITER OBSERVED A BALLOON FORMING ON THE WALL OF THE CATHETER OUTSIDE OF THE PENIS. BALLOON AT END OF CATHETER DID NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696403 ↗MalfunctionNov 4, 2025Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE PATIENT SAID HIS FOLEY WAS DEFECTIVE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23467058 ↗MalfunctionNov 3, 2025Disconnection; Disconnection
IT WAS REPORTED THAT FOLEY CATHETER CAP ON INFLATION LUMEN CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452640 ↗InjurySep 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ASSISTED URETEROSCOPY, LEFT FLEXIBLE URETEROSCOPY, LASER OF IMPACTED STONE ABOUT THE L2 LEVEL OF THE LEFT URETER, LASER OF BLADDER STONES, RETRIEVAL OF FRAGMENT OF LEFT SAFETY WIRE AND LEFT STENT PLACEMENT #24 X 6-FRENCH JJ STENT. AT THE CONCLUSION OF THE PROCEDURE THE DOCTOR PASSED "AN 18 F CUADE TIP (FOLEY) CATHETER AND THE EFFLUX WAS ONLY BLOOD TINGED." POST OP ORDERS INCLUDED FOLEY CATHETER HAND IRRIGATION Q 4HRS PRN [AS NEEDED] FOR HEMATURIA WITH NORMAL SALINE. ON POD [POST OPERATIVE DAY] #1, WHEN NURSE WENT TO IRRIGATE THE FOLEY CATHETER A POP OCCURRED. THE PROVIDER WAS IMMEDIATELY NOTIFIED AND ORDERS TO REPLACE THE FOLEY WAS GIVEN. THE FOLEY WAS REPLACED WITHOUT INCIDENT. A RENAL AND BLADDER US [ULTRASOUND] WAS PERFORMED WITH AN IMPRESSION OF NO HYDRONEPHROSIS, EMPTY BLADDER WITH FOLEY CATHETER IN PLACE, LEFT-SIDED NEPHROSTOMY CATHETER NON-OBSTRUCTING STONES RIGHT AND LEFT KIDNEY. IT WAS UNKNOWN THE CC OF SALINE USED TO FILL THE BALLOON AT THE TIME OF INSERTION BY THE PROVIDER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23073669 ↗InjuryJul 30, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT PATIENT PULLED FOLEY CATHETER OUT AND ONLY HALF CAME OUT, HAS A SURGERY SCHEDULED TO REMOVE THE OTHER HALF OF THE DEVICE. PATIENT HAD DEVICE IN FOR 20 DAYS WHEN THEY REMOVED IT, PATIENT HAS DEMENTIA. IT WAS NOTED THAT THE GIVEN LOT#NGJX0928. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 26AUG2025, IT WAS REPORTED THAT THE PRODUCT WAS SENT TO THE HOSPITAL. IT HAD TO BE SURGICALLY REMOVED BY CYSTOSCOPY.
Patient problems: Foreign Body In Patient
MAUDE report 22672147 ↗MalfunctionJul 30, 2025Disconnection; Disconnection
IT WAS REPORTED THAT FOLEY CATHETER WAS CHANGED WHEN CAP AT THE END POPPED OFF AND WAS ABLE TO SWITCH OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22665949 ↗MalfunctionJul 10, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE HOSPITAL USER INSERTED CATHETER AND INFLATED BALLOON WITH 10 MLS STERILE WATER. AFTER A FEW MINUTES OF LETTING THE BLADDER DRAIN, HOSPITAL USER NOTICED THAT THE GREEN TIP WHERE STERILE WATER WAS INSTILLED HAD FALLEN OFF AND THE STERILE WATER DRAINED OUT. HOSPITAL USER CALLED COWORKER TO LOOK AT CATHETER AND TO BRING ANOTHER CATHETER TO REINSERT. FORTUNATELY, PATIENT TOLERATED WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467902 ↗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 ↗InjuryJun 18, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE BALLOON INSIDE THE PATIENT WOULD NOT DEFLATE, THEY HAD TO POP THE BALLOON FROM THE OUTSIDE PUNCTURED THROUGH THE SKIN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22284919 ↗MalfunctionJun 17, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT HAD FOLEY CATHETER IN PLACE AND STATES THE BALLOON FAILED ON THREE SEPARATE OCCASIONS. STATES IT SEEMED TO HAVE BEEN LEAKING FROM THE INFLATION PORT (SLIGHTLY DIFFERENT THAN THE PREVIOUS TWO TIMES). EXPLAINED THAT THIS ISN'T COMMON AND ISN'T SUPPOSED TO HAPPEN WHILE USING THE FOLEYS. PATIENT MENTIONED THE FIRST DAY OUT RUNNING ERRANDS WITH HIS CATHETER HE DID HAVE SLIGHT BLEEDING. INFORMED PATIENT HE WOULD NEED TO CONTACT HIS HCP FOR ASSISTANCE WITH THE COMPLICATIONS. BLEEDING COULD BE FROM DIFFERENT REASONS THAT THE MANUFACTURER CANNOT DETERMINE. DISCUSSED THE STATLOCK TO REDUCE PISTONING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22234713 ↗MalfunctionJun 16, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT FOLEY CATHETER FAILED, IN PATIENT. FOLEY CATHETER HAD TO BE DEFLATED BY PIERCING THROUGH PATIENT'S SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22211153 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page