Bard Clean-Cath Intermittent CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 116
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 1
We found 15 models of Bard Clean-Cath Intermittent Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between May 3, 2017 and May 5, 2023 — classified as 25 injuries, 91 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (27 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Bard Clean-Cath Intermittent Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 11, 2021Terminated
The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Z-1431-2021 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported Bard Clean-Cath Intermittent Catheter problems
Device problems
- Material Twisted/Bent27
- Difficult to Insert17
- Failure to Align13
- Device Damaged Prior to Use8
- Material Fragmentation8
- Scratched Material8
- Break7
- Component Missing7
Patient problems
- No Known Impact Or Consequence To Patient46
- No Consequences Or Impact To Patient24
- No Clinical Signs, Symptoms or Conditions16
- Patient Problem/Medical Problem14
- Urinary Tract Infection14
- No Patient Involvement11
- Pain9
- Discomfort8
Bard Clean-Cath Intermittent Catheter models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Clean-Cath® Intermittent Catheter 420712CATHETER, UROLOGICAL1 recall4 reports
- Bard® Clean-Cath® Intermittent Catheter 421714CATHETER, UROLOGICAL29 reports
- Bard® Clean-Cath® Intermittent Catheter 423714CATHETER, UROLOGICAL25 reports
- Bard® Clean-Cath® Intermittent Catheter 421716CATHETER, UROLOGICAL14 reports
- Bard® Clean-Cath® Intermittent Catheter 421712CATHETER, UROLOGICAL10 reports
- Bard® Clean-Cath® Intermittent Catheter 423716CATHETER, UROLOGICAL10 reports
- Bard® Clean-Cath® Intermittent Catheter 420714CATHETER, UROLOGICAL7 reports
- Bard® Clean-Cath® Intermittent Catheter 420716CATHETER, UROLOGICAL6 reports
- Bard® Clean-Cath® Intermittent Catheter 423712CATHETER, UROLOGICAL4 reports
- Bard® Clean-Cath® Intermittent Catheter 420718CATHETER, UROLOGICAL2 reports
- Bard® Clean-Cath® Intermittent Catheter 420710CATHETER, UROLOGICAL1 report
- Bard® Clean-Cath® Intermittent Catheter 421710CATHETER, UROLOGICAL1 report
- Bard® Clean-Cath® Intermittent Catheter 421718CATHETER, UROLOGICAL1 report
- Bard® Clean-Cath® Intermittent Catheter 423710CATHETER, UROLOGICAL1 report
- Bard® Clean-Cath® Intermittent Catheter 423718CATHETER, UROLOGICAL1 report
Recent Bard Clean-Cath Intermittent Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CATHETER WAS BROKEN ON REMOVAL FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16875943 ↗InjuryMay 14, 2022Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE VINYL CATHETER HAD AN UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PER FOLLOW-UP INFORMATION RECEIVED FROM (B)(6) TEAM ON 20APR2022, STATED THAT THE PATIENT EXPERIENCED DISTRESS, ABDOMINAL PAIN. IT WAS ALSO STATED THAT THEY REQUIRED HOSPITALIZATION OR PROLONGED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTION. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body In Patient; Pain
MAUDE report 14402888 ↗MalfunctionApr 4, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS NOT CURVED ENOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13995025 ↗MalfunctionFeb 6, 2022Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THE VINYL CATHETER MADE THE PATIENT TO BLEED IN THE PAST. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA PHONE ON (B)(6) 2022, IT WAS STATED THAT THE VINYL CATHETER WAS A SUBSTITUTE BECAUSE THE CUSTOMER'S NORMAL CATHETERS WERE ON BACKORDER. THEY DESCRIBED THE CATHETER AS EXTREMELY SLIPPERY AND THEY HAD ISSUES WITH THE GRIPPER. THEY DESCRIBED THESE AS DIFFICULT FOR THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13467512 ↗InjurySep 21, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE INTERMITTENT CATHETER CAUSED A URINARY TRACT INFECTION TO THE PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 12505916 ↗MalfunctionAug 10, 2021Disconnection; Decrease in Pressure; Disconnection; Decrease in Pressure
IT WAS REPORTED THAT THE VINYL CATHETER WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12305233 ↗MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE VINYL CATHETER WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12305040 ↗MalfunctionAug 10, 2021Fracture; Fracture
IT WAS REPORTED THAT THE CATHETER WAS BROKEN AND CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12304353 ↗MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CATHETER WAS BROKE AND CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300302 ↗MalfunctionJun 28, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE VINYL CLEAN CATHETERS WERE TOO BIG AND DIFFICULT TO INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12081417 ↗MalfunctionMay 24, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETER WAS HARD TO INSERT SINCE IT WAS NOT CURVED ENOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11870612 ↗MalfunctionMay 18, 2021Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CATHETER HAD A TEAR OR RIP AT THE INSERTION END. THE CUSTOMER COMPLAINED THAT THE CATHETER TORE THE PATIENT'S URETHRA AND THE PATIENT HAD TO GO TO THE EMERGENCY DEPARTMENT. THE PROBLEM WAS IDENTIFIED DUE TO THE AMOUNT OF BLOOD LOSS PRIOR GOING TO THE EMERGENCY DEPARTMENT. THE PATIENT HAD EXCESSIVE BLEEDING. THE PATIENT WAS ON BLOOD THINNERS AND THEY BELIEVED THAT IT WAS HEALED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11842012 ↗MalfunctionMay 14, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETERS WERE NOT ANGLED THE SAME WAY HENCE IT DID NOT GO IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11827113 ↗MalfunctionApr 8, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER WAS TWISTED AND UNABLE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11636937 ↗InjuryApr 8, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION WITH BAR421712 (VINYL CATHETER) AND REQUESTED TO SEND MTG32112, BECAUSE THEY ARE MORE STERILE THAN THE KITS THE PATIENT WAS GETTING IN PREVIOUS ORDER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 11636550 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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