Bardex I.C. Carson Model Coude Tip 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
- 38
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 5 models of Bardex I.C. Carson Model Coude Tip Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2018 and Aug 31, 2026 — classified as 15 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (12 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 I.C. Carson Model Coude Tip Foley Catheter problems
Device problems
- Material Rupture12
- Material Fragmentation7
- Material Puncture/Hole3
- Dent in Material2
- Difficult to Remove2
- Fluid/Blood Leak2
- Inflation Problem2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Foreign Body In Patient9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Known Impact Or Consequence To Patient3
- Patient Problem/Medical Problem3
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- No Code Available1
Bardex I.C. Carson Model Coude Tip Foley Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI16CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES27 reports
- Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI18CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES4 reports
- Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI20CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES4 reports
- Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI14CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Carson Model Coude Tip Foley Catheter 0168SI12CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
Recent Bardex I.C. Carson Model Coude Tip Foley Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Inflation Problem; Dent in Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50522637 ↗InjuryNov 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE EMERGENCY DEPARTMENT BECAUSE THEIR FOLEY FELL OUT. THEY HAD PICTURES OF THE CATHETER IT LOOKED AS THOUGH THE BALLOON JUST BURST. THEY ALSO HAD PICTURES THE PACKAGING AND LOT NUMBER IN THE FORM. THEY SENT THEM A TASK. UNEXPECTED MEDICAL INTERVENTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23541933 ↗InjuryNov 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE JUST SAW AN AWARE 230007 FROM (B)(6) HOSPITAL WHERE A PATIENT CAME BACK TO THE EMERGENCY DEPARTMENT BECAUSE THE FOLEY ¿FELL OUT¿. PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AFTER INDWELLING URETHRAL CATHETER "FELL OUT". ON ARRIVAL CATHETER NO LONGER IN PLACE. PATIENT RETURNED HOME AND WHEN GETTING OUT OF THE CAR REPORTS NOTICED THAT HIS PANTS WERE GETTING WET. SEE ATTACHMENTS FOR THE CONDITION OF FOLEY CATHETER. THEY HAVE PICTURES OF THE CATHETER IT LOOKS AS THOUGH THE BALLOON JUST BURST. THEY ALSO HAVE PICTURED THE PACKAGING AND LOT NUMBER IN THE FORM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23518897 ↗MalfunctionAug 25, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE AIDE WENT TO DO FOLEY CARE ON PATIENT AND DISCOVERED FOLEY WAS NO LONGER IN PATIENT. BALLOON WAS NOT INFLATED. DISCOVERED BALLOON SYRINGE CONNECTION PIECE WAS MISSING FROM FOLEY. FOUND PIECE IN BED UNDER PATIENT. UNSURE HOW CONNECTOR BECAME DISCONNECTED FROM FOLEY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 27AUG2025, IT WAS REPORTED THAT NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22887588 ↗MalfunctionJul 21, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT WHEN THEY REMOVED A FOLEY FROM A FEMALE PATIENT AND THE BALLOON HAD A HOLE IN IT AND WAS ALREADY DEFLATED WHEN THEY WENT TO REMOVE IT. WHEN TESTED THE BALLOON AFTER AND I WOULD NOT HOLD AIR OR FLUID. IT WAS INTACT BUT LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554331 ↗InjuryJun 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT PATIENT UNDERGOING C5 GEMZAR/TAXOTERE BLADDER INSTILLATION HAD A FOLEY CATHETER INSERTED WITHOUT ISSUES. AFTER ADMINISTERING GEMZAR AND TAXOTERE, THE PATIENT HEARD A POP AND NEEDED A BOWEL MOVEMENT. WHILE IN THE RESTROOM, ANOTHER POP WAS HEARD, AND THE FOLEY CATHETER CAME OUT AS THE PATIENT URINATED. THE PATIENT REPORTED NO PAIN OR BLOOD IN THE URINE. A STAT BLADDER ULTRASOUND WAS ORDERED, AND A CYSTOSCOPY THE NEXT DAY REMOVED THE FOLEY BALLOON FOREIGN BODY.
Patient problems: Foreign Body In Patient
MAUDE report 22320007 ↗InjuryJun 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THIS PATIENT WAS NOTED TO HAVE A RETAINED FOREIGN BODY. THEY SUSPECTED TO BE A URINARY FOLEY CATHETER BALLOON FRAGMENT AFTER CHEMOTHERAPY BLADDER INSTILLATION WHICH WAS RESULTING IN FURTHER FOLLOW-UP WITH UROLOGY FOR REMOVAL. THE DEVICE WAS RETAINED AND EVALUATED BY THE DEPARTMENT LEADER. THE FINDINGS PRESENT CONCERNS FOR A LIKELY INDWELLING URINARY CATHETER PRODUCT MALFUNCTION. THE SUPPLY CHAIN SERVICES MANAGER WAS WORKING WITH THE LEADER ON INITIAL IMMEDIATE STEPS. LOT#NGJX4559 AND LOT#NGJY3539.
Patient problems: Foreign Body In Patient
MAUDE report 22194628 ↗InjuryJun 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THIS PATIENT WAS NOTED TO HAVE A RETAINED FOREIGN BODY. THEY SUSPECTED TO BE A URINARY FOLEY CATHETER BALLOON FRAGMENT AFTER CHEMOTHERAPY BLADDER INSTILLATION WHICH WAS RESULTING IN FURTHER FOLLOW-UP WITH UROLOGY FOR REMOVAL. THE DEVICE WAS RETAINED AND EVALUATED BY THE DEPARTMENT LEADER. THE FINDINGS PRESENT CONCERNS FOR A LIKELY INDWELLING URINARY CATHETER PRODUCT MALFUNCTION. THE SUPPLY CHAIN SERVICES MANAGER WAS WORKING WITH THE LEADER ON INITIAL IMMEDIATE STEPS. LOT#NGJX4559 AND LOT#NGJY3539.
Patient problems: Foreign Body In Patient
MAUDE report 22186319 ↗MalfunctionJun 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PHARMACIST STATED THAT THEY USED SURESTEP FOLEY TRAY A304716A FOR CHEMOTHERAPY IN THE BLADDER. THE FOLEY CATHETER BALLOON BURST, EVEN THOUGH THEY HAVE DONE THIS PROCESS MANY TIMES BEFORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22186313 ↗InjuryMay 23, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FOLEY CATHETER BROKE APART WHILE IN THE PATIENTS. NOT SURE IF THERE HAS BEEN ANY MEDICAL INTERVENTION YET. IT WAS NOTED THAT THE GIVEN LOT# WAS NGKN2100. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 06MAY2025, THE RUPTURED BALLOON PIECES WERE IN THE ANATOMIC PATHOLOGY DEPARTMENT. THESE COULD NOT BE RELEASED WITHOUT PATIENT PERMISSION. FOR PATIENT NUMBER 1 URINARY TRACT INFECTION AND FOUND ON A ROUTINE CYSTOSCOPY. FOR PATIENT NUMBER 2 UNSCHEDULED CYSTOSCOPY PERFORMED.
Patient problems: Foreign Body In Patient
MAUDE report 22078278 ↗InjuryMay 9, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER RUPTURE OCCURRED. LATER THE BALLOONS WERE RETRIEVED BY PERFORMING A CYSTOSCOPY ON THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21993844 ↗InjuryMay 9, 2025Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture
IT WAS REPORTED THAT THE FOLEY CATHETER RUPTURE OCCURRED. THE BALLOONS WERE RETRIEVED BY PERFORMING A CYSTOSCOPY ON THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21993843 ↗InjuryMay 5, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FOLEY CATHETER BROKE APART WHILE IN THE PATIENTS. NOT SURE IF THERE HAS BEEN ANY MEDICAL INTERVENTION YET. IT WAS NOTED THAT THE GIVEN LOT# WAS NGKN2100.
Patient problems: Foreign Body In Patient; Urinary Tract Infection
MAUDE report 21960954 ↗InjuryApr 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT FOLEY CATHETER BALLOON FAILURE CAUSED A RETAINED FOLEY BALLOON IN THE BLADDER AND LEFT PART OF THE FOLEY BALLOON IN A PATIENT UPON REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 21839173 ↗InjuryApr 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT CUSTOMER STATED ITEM NUMBER 0168SI18 FOLEY BALLOON CATHETER EXPLODED ON PATIENT. PER NOTATION PATIENT ACCOUNT HAD TO GO TO THE HOSPITAL DUE TO THAT FOLEY ISSUE. UNFORTUNATELY THEY WERE UNABLE TO PROVIDE THEM WITH A LOT NUMBER FROM THE FAULTY FOLEY. THAT PRODUCT HAD BEEN DISPOSED OF BY THE HOSPITAL STUFF UNABLE TO RECOVER. THEY ALREADY CREDITED PRODUCT FOR OUR CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21824976 ↗
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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