Bard® All Purpose Urethral Catheter 0094200Recalls & reported problems
C. R. Bard, Inc. · Bard® All Purpose Urethral Catheter · Class 2
All models of Bard All Purpose Urethral Catheter (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741034053), received between Apr 7, 2021 and Apr 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).
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
- Material Too Rigid or Stiff1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 7, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE PATIENT HAD BEEN USING A COUPLE OF BARD RED RUBBER CATHETERS FOR YEARS (PCN (B)(4)). PATIENT WANTED TO KNOW WHY THERE WAS SUCH A DIFFERENCE IN THE DUROMETER BETWEEN THESE TWO CATHETERS AND REPORTED THAT CATHETER 94200 WAS THE HARDEST, AND PATIENT HAD JUST POKED A HOLE IN THE COLON. PATIENT HAD THEN STARTED ANTIBIOTICS AND DECIDED TO GO TO THE HOSPITAL LATER. PATIENT DID NOT THINK THAT THIS WAS A DEFECT IN THE PRODUCT, AND WAS ONLY CURIOUS AS TO WHY THERE WAS SUCH A DIFFERENCE BETWEEN THE TWO CATHETERS. PER FOLLOW UP VIA PHONE ON (B)(6) 2021, THE CUSTOMER STATED THAT THE 94200 CATHETERS IN THE MOST RECENT ORDER WERE HARDER THAN PREVIOUS ONCE RECEIVED. THE CUSTOMER NOTED THE CATHETER POKED A HOLE IN THE COLON AND RESULTED IN BLEEDING. THE BLEEDING STOPPED ON ITS OWN BUT THE CUSTOMER WAS PRESCRIBED ANTIBIOTICS AS A PRECAUTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11626777 ↗
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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