Bard® Clean-Cath® Intermittent Catheter 420716Recalls & reported problems
C. R. Bard, Inc. · Bard® Clean-Cath® Intermittent Catheter · Class 2
All models of Bard Clean-Cath Intermittent Catheter (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741038754), received between Aug 22, 2019 and Aug 6, 2020 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility4
- Adverse Event Without Identified Device or Use Problem2
- Biocompatibility1
- Deformation Due to Compressive Stress1
- Material Twisted/Bent1
Patient problems
- Urinary Tract Infection5
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Deformation Due to Compressive Stress; Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SOME INTERMITTENT CATHETERS SEEMED TO BE NOT STRAIGHT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10375956 ↗InjuryMar 25, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility
IT WAS REPORTED THAT THE PATIENT HAD SEVERAL URINARY TRACT INFECTIONS, AND THOUGHT IT COULD BE FROM THE USE OF THE CATHETERS.
Patient problems: Patient Problem/Medical Problem; Urinary Tract Infection
MAUDE report 9880373 ↗InjuryNov 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SAID SHE WAS GETTING UTIS. SHE SAID SHE WANTED TO CONTINUE TO USE THE CATHETER. IT IS CURRENTLY UNKNOWN IF THE PATIENT RECEIVED MEDICAL INTERVENTION.
Patient problems: Urinary Tract Infection
MAUDE report 9306348 ↗InjuryAug 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES OF URINARY TRACT INFECTIONS WITH THE USE OF THE CATHETERS. MEDICAL INTERVENTION IS UNKNOWN.
Patient problems: Urinary Tract Infection
MAUDE report 8925414 ↗InjuryAug 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES OF URINARY TRACT INFECTIONS WITH THE USE OF THE CATHETER. MEDICAL INTERVENTION IS UNKNOWN.
Patient problems: Urinary Tract Infection
MAUDE report 8923405 ↗InjuryAug 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INSTANCES OF URINARY TRACT INFECTIONS WITH THE USE OF THE CATHETERS. MEDICAL INTERVENTION IS UNKNOWN.
Patient problems: Urinary Tract Infection
MAUDE report 8923161 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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