Bardex Silicone Coated Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 13 models of Bardex Silicone Coated Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2017 and Sep 25, 2026 — classified as 4 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (16 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 Silicone Coated Foley Catheter problems
Device problems
- Material Puncture/Hole16
- Material Rupture15
- Material Fragmentation7
- Disconnection6
- Failure to Infuse6
- Inaccurate Flow Rate5
- Deflation Problem4
- Difficult to Remove4
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- Foreign Body In Patient3
- Discomfort2
- Hematuria2
- No Patient Involvement2
Bardex Silicone Coated Foley Catheter models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Silicone Coated Foley Catheter 0166V16SCATHETER, UROLOGICAL37 reports
- Bardex® Silicone Coated Foley Catheter 0165V18SCATHETER, COUDE12 reports
- Bardex® Silicone Coated Foley Catheter 0166V14SCATHETER, UROLOGICAL8 reports
- Bardex® Silicone Coated Foley Catheter 0165V22SCATHETER, COUDE5 reports
- Bardex® Silicone Coated Foley Catheter 0165V24SCATHETER, COUDE5 reports
- Bardex® Silicone Coated Foley Catheter 0165V16SCATHETER, COUDE4 reports
- Bardex® Silicone Coated Foley Catheter 0165V20SCATHETER, COUDE4 reports
- Bardex® Silicone Coated Foley Catheter 0166V18SCATHETER, UROLOGICAL4 reports
- Bardex® Silicone Coated Foley Catheter 0166V12SCATHETER, UROLOGICAL3 reports
- Bardex® Silicone Coated Foley Catheter 0165V14SCATHETER, COUDE2 reports
- Bardex® Silicone Coated Foley Catheter 0166V20SCATHETER, UROLOGICAL2 reports
- Bardex® Silicone Coated Foley Catheter 0165V28SCATHETER, COUDE1 report
- Bardex® Silicone Coated Foley Catheter 0166V30SCATHETER, UROLOGICAL1 report
Recent Bardex Silicone Coated 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 25, 2026Inaccurate Flow Rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903531 ↗MalfunctionSep 5, 2026Material Invagination; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50634878 ↗MalfunctionJul 10, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25787473 ↗InjuryJun 11, 2026Difficult to Remove
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF CEREBRAL HEMORRHAGE, AND AFTER ADMISSION, THE CATHETER WAS REMOVED ON (B)(6) 2026, AND IT WAS FOUND THAT FLUID COULD NOT BE WITHDRAWN FROM THE BALLOON. TO RULE OUT THE CAUSE, WITHOUT VIOLENCE, HE WAS GIVEN AN IMMEDIATE REPLACEMENT OF STERILE SCISSORS TO CUT OFF THE END OF THE BALLOON IN ORDER TO REMOVE THE URINARY CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 25479042 ↗MalfunctionMay 11, 2026Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT DURING INTRAOPERATIVE INDWELLING OF THE URINARY FOLEY CATHETER, THE PATIENT'S URINE MAY NOT BE ABLE TO BE EXPELLED DUE TO BALLOON LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144083 ↗MalfunctionMar 24, 2026Material Rupture
IT WAS REPORTED THAT ON (B)(6) 2026, AT 09:15, THE DOCTOR FOUND THAT THE FOLEY CATHETER BALLOON RUPTURED WHEN REMOVING THE TUBE AT THE BEDSIDE. THERE WAS NO RESIDUE IN THE PATIENT'S BODY, AND THE PATIENT DID NOT REPORT ANY DISCOMFORT. A CATHETER WAS SUBSEQUENTLY REPLACED AT THE BEDSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682737 ↗MalfunctionMar 9, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT THAT URINE DID NOT FLOW TO THE BAG AFTER 2HRS INSERTED THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545349 ↗MalfunctionMar 7, 2026Material Puncture/Hole
THE PATIENT WAS ADMITTED TO THE DEPARTMENT OF RESPIRATORY AND CRITICAL CARE MEDICINE ON (B)(6) 2026, PRESENTING WITH COUGH AND PHLEGM PRODUCTION FOR OVER ONE MONTH. A URINARY FOLEY CATHETER WAS REPLACED ON THE DAY OF ADMISSION. AROUND 19:10 ON (B)(6) 2026, THE CATHETER SPONTANEOUSLY DISLODGED, CAUSING URINE LEAKAGE. THE PHYSICIAN REINSERTED THE CATHETER. DURING THE AFTERNOON SHIFT, THE NURSE INFLATED THE CATHETER'S WATER BALLOON AND SUBMERGED IT IN A CUP OF WATER. SMALL BUBBLES WERE OBSERVED RISING, THOUGH NO VISIBLE TEAR WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539943 ↗MalfunctionJan 26, 2026Material Puncture/Hole
IT WAS REPORTED THAT, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY ON (B)(6) 2025. AT 7:50 AM ON (B)(6) 2025, WHILE DEFECATING, THE PATIENT FELT THE URINARY FOLEY CATHETER SLIP OUT AND NOTICED URINE OVERFLOWING FROM THE URETHRAL OPENING. THE CATHETER WAS OBSERVED TO HAVE DISLODGED FROM THE URETHRA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185530 ↗MalfunctionJan 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE, LEAKAGE OCCURRED IN THE FOLEY CATHETER. REPLACED WITH SECONDARY CATHETER PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24103160 ↗MalfunctionJan 14, 2026Material Rupture
IT WAS REPORTED THAT, AFTER DRAINING URINE FROM THE PATIENT, THE URINARY FOLEY CATHETER WAS REMOVED, REVEALING A RUPTURED WATER BLADDER. IMMEDIATELY INSPECT THE CATHETER FOR INTEGRITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24070252 ↗MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT ONE PACKAGE OF 8 URINARY CATHETERS CONTAINED SHREDDED PAPER AND ONE PRODUCT EXHIBITED AIR LEAKAGE. (125816C- LOT # MYHW3462- (OCCURRENCE 1)), (123614C- LOT # MYHT0905 (OCCURRENCE 1), (125818C- LOT # MYGV4245 (OCCURRENCE 4)), (123422C-LOT # MYGY4017 (OCCURRENCE 3).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929060 ↗MalfunctionDec 10, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT, THE WATER IN THE BALLOON OF THE FOLEY CATHETER FLUID COULD NOT BE PUMPED BACK OUT DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772202 ↗MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT, AFTER INSERTING THE URINARY FOLEY CATHETER, THE PHYSICIAN DISCOVERED A LEAK AT THE CATHETER SITE AND IMMEDIATELY REMOVED AND REPLACED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771830 ↗MalfunctionNov 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT ONE PACKAGE OF 8 URINARY CATHETERS CONTAINED SHREDDED PAPE N(LOT#MYGV4245- OCCURENCE-3), (LOT#MYGY4017, OCCURENCE-3) , 1(LOT#MYHW3462, OCCURENCE-1)]", (LOT#MYHT0905, OCCURENCE-1)]" AND ONE PRODUCT EXHIBITED AIR LEAKAGE (LOT#MYGV4245- OCCURENCE-1).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657706 ↗
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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